FEBRUARY 2012

WEEK ENDING FEBRUARY 25

Regeneca, Inc. Issues a Recall of All Lots of Single Capsule RegenErect Because of Potential Health Risks 

Regeneca, Inc. (Pink Sheets:RGNA) is recalling all lots of single capsule packet RegenErect, labeled as a dietary supplement. The company has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

Regeneca, Inc. has distributed RegenErect via sales made over the internet to consumers in the United States of America and Puerto Rico, and given as samples at public events.

RegenErect, is a blue capsule sold individually in foil packets with a UPC code of 816860010055. .

Regeneca, Inc. advises any customers in possession of the RegenErect product above to return any unused product for an exchange, or a full refund, to the company directly. 

Customers can call (800) 690-6958 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process. 

Glenmark Generics Inc. Announces a Recall of Seven (7) Lots of
Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215
mg/0.035 mg, 0.25 mg/0.035 mg (Generic) 

Glenmark Generics Inc. USA is recalling seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch. 

These tablets were manufactured and packaged by Glenmark Generics Ltd. India. and are distributed by Glenmark Generics Inc. USA. This product is distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011. This product is distributed by Glenmark Generics Inc. only in the USA.

Lot numbers of affected packs of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (Generic), are as follows:

NDC Lot Nos Expiration
68462-565-29 04110101 07/31/2013
04110106 07/31/2013
04110107 07/31/2013
04110114 08/31/2013
04110124 08/31/2013
04110129 08/31/2013
04110134 09/30/2013

Any adverse events that may be related to the use of these products should be reported to Glenmark Generics Inc., USA at 1-(888)721-7115 (8 AM to 5 PM Mon-Fri EST) or to FDA's MedWatch Program either online, by regular mail or by fax.

PRODUCT
1) Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension), 1,200,000 units per 2 mL, Ten Syringes (2 mL size), Rx only. NDC 60793-600-10. 
 
2) Bicillin L-A (penicillin G benzathine injectable suspension), 1,200,000 units per 2 mL, Ten Syringes (2 mL size), Rx only. NDC 60793-701-10. 
 
3) GONAL- f RFF Pen (follitropin alfa injection) 900 IU/1.5 mL, For Subcutaneous injection, Rx only, NDC 44087-1114-1. 
 
4) PULMOZYME (DORNASE ALFA) INHALATION SOLUTION, 30 Ampules, NDC 50242-100-40.
 
5) Rebif (Interferon beta-1a) 44 mcg/0.5 mL, 12 Single-use prefilled syringes, NDC 44087-0044-3. 
 
6) VSL #3 DS (DOUBLE STRENGTH), 20 SACHETS, Prescription only, Product Code 45749-017-82, NDC 45749-017-82,
CODE
1) Lot #: 60746;  
2) Lot #: 61331;
3) Lot #: BA002807;
4) Lot #: 867896;
5) Lot #: AU000878;
6) Lot #: 2448A11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kinray Inc., Whitestone, NY, 
Manufacturers: King Pharmaceuticals
Genentech Inc., South San Francisco, CA. 
REASON Temp Abuse: Kinray Inc. is recalling these products because a refrigeration unit at their distribution facility malfunctioned, causing the temperature to rise above the storage specification.
VOLUME OF PRODUCT IN COMMERCE 17 units
DISTRIBUTION NY, NJ, and MA

 

PRODUCT OFIRMEV, (acetaminophen) injection, 1000 mg/100 mL, (10 mg/mL, For Intravenous Use Only, Rx Only, NDC 43825-102-01, is supplied in a 100mL glass vial, containing 1000mg acetaminophen (10mg/mL) OFIRMEV (acetaminophen), NDC 43825-102-01.
CODE Lot V005710, Exp. 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cadence Pharmaceuticals, San Diego, CA,
Manufacturer: Baxter Healthcare Corp, Cleveland, MS.
REASON Presence of Particulate Matter: An unidentified visible particle was found in one vial during routine stability testing.
VOLUME OF PRODUCT IN COMMERCE 33,336 vials
DISTRIBUTION Nationwide

 

PRODUCT
1) Assured Pain Relief for Arthritis, (Acetaminophen 650mg), 24 Caplets (NDC 45738-717-24);
2) Consumer's Choice Pain Relief for Arthritis, (Acetaminophen 650mg), a) 100 Caplets (NDC 45738-715-10), b) 24 Caplets (NDC 45738-715-24);
3) Preferred plus Acetaminophen for Arthritis (Acetaminophen 650mg), 100 Caplets (NDC 45738-716-10);
4) Quality Choice Arthritis Pain Relief (Acetaminophen 650mg), a) 50 Caplets (NDC 63868-089-50), b) 100 Caplets (NDC 63868-089-01);
5) Select Brand Arthritis Pain Relief (Acetaminophen 650mg), a) 100 Caplets (NDC 15127-530-01) b) 24 Caplets (NDC 15127-530-24), c) 50 Caplets (NDC 15127-530-50);
6) Premier Value Arthritis Pain Relief (Acetaminophen 650mg), a) 50 Caplets (NDC 68019-019-45), b) 100 Caplets (NDC 68016-021-06). 
CODE
1) Lot # 10J745, Exp Date Sep-12; Lot # 10J746, Exp Date Sep-12; Lot # 10J747, Exp Date Sep-12; Lot # 10K798, Exp Date Oct-12; Lot # 10K814, Exp Date Oct-12; Lot # 10K814, Exp Date Oct-12; Lot # 10K799, Exp Date Oct-12; Lot # 10K816, Exp Date Oct-12; Lot # 10K861, Exp Date Oct-12; Lot # 10L861, Exp Date Nov-12; Lot # 10L862, Exp Date Nov-12; Lot # 10L862, Exp Date Nov-12; Lot # 10L863, Exp Date Nov-12; Lot # 10L891, Exp Date Nov-12; Lot # 10L890, Exp Date Nov-12; Lot # 11A004, Exp Date Jan-13; Lot # 11A004, Exp Date Jan-13; Lot # 11A062, Exp Date Jan-13; Lot # 11A061, Exp Date Jan-13; Lot # 11A062, Exp Date Jan-13; Lot # 11A062, Exp Date Jan-13 & Lot # 11G481, Exp Date Jul-13;
2) Lot # 10L889, Exp Date Nov-12; Lot # 10L890, Exp Date Nov-12; and Lot # 10L863, Exp Date Nov-12; Lot # 10L889, Exp Date Nov-12 & Lot # 11A062, Exp Date Jan-13;
3) Lot # 10K799, Exp Date Oct-12; Lot # 10L863, Exp Date Nov-12; Lot #, 11A061, Exp Date, Jan-13 & Lot # 11A062, Exp Date Jan-13;
4) Lot # 11A004, Exp Date Jan-13; Lot # 11A060, Exp Date Jan-13; Lot # 11H484, Exp Date Jul-13 & NDC 63868-089-50, Lot # 11A004, Exp Date Jan-13;
5) Lot # 10K816, Exp Date Oct-12; Lot #, 10L863, Exp Date, Nov-12; Lot # 11A004, Exp Date Jan-13; NDC 15127-530-24, Lot # 10K814, Exp Date Oct-12; Lot # 11A004, Exp Date Jan-13; Lot # 11A062, Exp Date Jan-13; Lot # 10K814, Exp Date Oct-12; Lot # 11A004, Exp Date Jan-13 & Lot # 11A062, Exp Date, Jan-13;
6) All Lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aphena Pharma Solutions LLC, Glasgow, KY,
Manufacturer: Advance Pharmaceutical Inc., Ronkonkoma, NY. 
REASON Marketed without an approved NDA/ANDA: The recall is due to incorrect dosage information indicated on the primary bottle and the outside carton labeling. The labeling contained the following information: take 2 caplets every 8 hours with water. This labeling exceeds the allowable monograph quantity of acetaminophen in an 8 hour period.
VOLUME OF PRODUCT IN COMMERCE 1,050,943 bottles
DISTRIBUTION Nationwide

 

PRODUCT
1) DynaCirc CR (isradipine) Controlled Release Tablets, 5 mg, 30-count bottles, Rx only; NDC 0173-0784-01; UPC 3 0173-0784-01 8. 
 
2) DynaCirc CR (isradipine) Controlled Release Tablets, 10 mg, 30-count bottles, Rx only; NDC 0173-0785-01, UPC 3 0173-0785-01 5. 
CODE
1) Lot #: 10084536, Exp 12/12; 10102915, Exp 03/13; 10102916, Exp 06/13; 10107157, Exp 07/13; and 10108172, Exp 09/13;
 
2) Lot #: 10087732, Exp 01/13; 10091069, 10094639; Exp 03/13; 10102913, Exp 07/13; and 10109327, Exp 10/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline Inc., Zebulon, NC,
Manufacturers: Novartis Consumer Health, Lincoln NB;
Patheon Pharmaceuticals Inc., Cincinnati, OH. 
REASON CGMP Deviations: These lots are being recalled due to compliance concerns regarding the level of cGMP compliance and procedural controls related to line clearance during the packaging process at the Novartis Consumer Health, site.
VOLUME OF PRODUCT IN COMMERCE 394,230 bottles
DISTRIBUTION Nationwide

 

PRODUCT
1) Female One Series Vagifresh Moisturizing Gel, 2 fl. oz. (59mL) carton, Made in U.S.A. UPC Code: 689076499057. 
 
2) Female One Series Vagifresh Ball, 3 tablets per carton, UPC Code: 689076499156. 
CODE All Lots.
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.S.A Far Ocean Group LLC, Alhambra, CA,
Manufacturer: Essential Pharmaceutical Corp, Pomona, CA. .
REASON
1) Labeling: Product contains Undeclared Active Ingredient; The recall was initiated because Far Ocean Group has confirmed that the Vagifresh Gel contains Benzocaine, an active ingredient for many anesthetic drug products.
2) Microbial Contamination of Non-Sterile Products; Far Ocean Group and FDA lab analysis confirmed that the Vagifresh Ball contains bacteria that may be a potential health risk.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide and China, South Africa, and Canada
 
PRODUCT
1) Motrin IB, Ibuprofen Tablets USP 200 mg, Pain Reliever/Fever Reducer (NSAID), 24 Coated Tablets, NDC 50580-109-02. 
 
2) Motrin IB, Ibuprofen Tablets USP 200 mg, Pain Reliever/Fever Reducer (NSAID),24 Coated Caplets, NDC 50580-110-03. Motrin IB***Ibuprofen Tablets, USP 200 mg*** 24+6 Coated Caplets***. Motrin IB 24 Count Coated Caplets, Motrin IB 24+6 Coated Caplets. Cartons of Motrin IB Coated Caplets were also included in the following displays: TYl ES/PM CAP 24s, Motrin CAP 24s CU (Display case UPC# 30300450753312); Tylenol Caplet 24/Motrin Caplet 24 (Display case UPC# 30300450749230); Tylenol RRG/PM 24s, Motrin CAP 24s CU (Display case UPC# 30300450754821); and TYl ES/PM/RRG/MOT IB/PM 24s DIST PK (Display case UPC# 30300450755873). 
CODE
1) Lot ADA069, Exp. 01/12; ALA168, Exp. 04/12; ALA244, Exp. 08/12; AMA286, Exp. 09/12; APA001, Exp. 09/12; ASA001, Exp. 10/12;
 
2) Lot ACA310, Exp. 12/11; ACA460, Exp. 01/12; ADA407, Exp. 02/12; AEA262, Exp. 03/12; AFA226, Exp. 04/12; AJA170, Exp. 03/12; ALA037, Exp. 07/12; ALA163, Exp. 04/12; AMA012, Exp. 08/12; AMA331, Exp. 05/12; AMA342, Exp. 08/12; APA035, Exp. 09/12; ASA082, Exp. 09/12; ASA123, Exp. 10/12; ASA285, Exp. 09/12; BDA238, Exp. 11/12; BDA260, Exp. 01/13; BDA383, Exp. 01/13; BEA065, Exp. 01/13; BEA148, Exp. 02/13; Exp. 03/13; BEA269, Exp. 03/13; BEA277, Exp. 03/13; BFA064, Exp.04/13; BFA144, Exp. 04/13; BFA244, Exp. 05/13; BHA078, Exp. 05/13; BHA147, Exp. 04/13; BHA167, Exp. 04/13; BHA198, Exp. 05/13; BJA164, Exp. 05/13; BJA221, Exp/. 06/13; BMA144, Exp. 08/13; BMA215, Exp. 08/13; BMA271, Exp. 08/13; BSA022, Exp. 07/13; BSA056, Exp. 10/13; CBA063, Exp. 12/13; CBA107, Exp. 12/13; CCA028, Exp. 01/14; CDA003, Exp. 02/14; CFA065, Exp. 01/14; CFA100, Exp. 01/14; CHA012, Exp. 01/14; CHA044, Exp. 01/14; CHA066, Exp. 01/14; CHA080, Exp. 05/14; CMA028, Exp. 05/14; CMA035, Exp. 05/14; CMA057, Exp. 05/14; CMA102, Exp. 06/14; CMA108, Exp. 05/14; ACA761, Exp. 01/12; ALA265, Exp. 08/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div Of McNeil-ppc, Inc, Fort, Washington, PA, 
Manufacturer: Dr. Reddy's Laboratories Louisiana LLC, Shreveport, LA. 
REASON Failed USP Dissolution Test Requirements: McNeil is recalling these products because testing of product sample showed that some caplets may not dissolve as quickly as intended when nearing their expiration date.
VOLUME OF PRODUCT IN COMMERCE 11,990,160 bottles
DISTRIBUTION Nationwide and Puerto Rico, Bahamas, Belize, Fiji, Jamaica and Saint Lucia

American Regent Initiates Recall Of Phenylephrine HCl Injection, USP, 1% 5 mL Vial, Lot# 0693 Due To Visible Particles

American Regent is conducting a recall of the following product: 

Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vial NDC # 0517-0405-25, Lot # 0693, Exp Date: October, 2012.
 

American Regent is undertaking this recall of Phenylephrine HCl Injection, USP, Lot 0693 due to potential safety concerns stemming from the identification of visible particles found in some retained samples of this lot. 

The product was distributed to wholesalers and distributors nationwide.

Hospitals, Emergency Rooms, Clinics, and other healthcare facilities and providers should not use American Regent, Inc., Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vials, with Lot #0693, for patient care and should immediately quarantine any product for return.

American Regent is notifying its distributors and consumers by e-mail, facsimile and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts for all returned Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vials, with Lot # 0693. Those with questions about the return or recall process, please call our Customer Service Department at 1- 800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, emergency rooms, clinics, and other healthcare facilities and providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232: Monday thru Friday from 9:00 AM to 5:00 PM ET.

Healthy People Co. is Expanding its Recall Include Dietary Products 

Healthy People Co. is expanding its recall of the company’s dietary supplements sold under the brand names described below, regardless of the lot numbers referenced herein.

Healthy People Co. conducted a  recall because lab analysis confirmed the presence of Sibutramine and Tadalafil in the products identified herein, making the following products unapproved new drugs:

MINCE BELLE (Dietary Supplement, 30 Capsules)
LOT: HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021, HPCMB/10-016; UPC7503013203305

EVERLAX (Dietary Supplement, 30 Capsules)
LOT: HPCEX/074, HPCEX/076, HPCEX/072, HPCEX/032; UPC7503013203046

EVER SLIM (Dietary Supplement, 30 Capsules)
LOT: HPCES-079, HPCES-070, HPCES-071, HPCES/038; UPC7503013203053

EVER SLIM Shake Mix (Dietary Supplement Strawberry Contents17.6 oz.)
LOT: HPESSF/168: UPC7503013203084

EVER SLIM Shake Mix (Dietary Supplement Chocolate Contents17.6 oz.)
LOT: HPESSC/061: UPC7503013203077

ACAI-MAN MANGOSTEEN Herbal Drink (Dietary Supplement Contents 16.6 oz.)
LOT: HPJAC/004: UPC7503013203015

PERFECT MEN (Dietary Supplement, 10 Capsules)
LOT: HPCPM/002; UPC7503013203190

Healthy People Co. advises its distributors and customers in possession of the brand names listed above, to return any unused product to our store located in 13105 Ramona Blvd Ste F, Irwindale, CA, 91706. Healthy People Co. will replace any returned products of the brand names listed above, regardless of the lot numbers referenced herein, to the extent these products were bought on or before October 25, 2011. 

Customers can call 626-939-4132 M-F 9am-5pm (PST) for instructions on the return process.

These products were distributed nationwide.

WEEK ENDING FEBRUARY 18

McNeil Consumer Healthcare Announces Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. (“McNeil”), is recalling seven lots, approximately 574,000 bottles, of Infants’ TYLENOL Oral Suspension, 1 oz. Grape distributed nationwide in the United States (see full product list below). 

McNeil is initiating this recall as a precaution after receiving complaints from consumers who reported difficulty using the Infants’ TYLENOL SimpleMeasure dosing system.

Consumers can request a refund by visiting www.tylenol.com  or contacting McNeil at 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time; Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). 
FULL RECALLED PRODUCT LIST: 

Product Name Lot Numbers UPC Code
Infants’ TYLENOL Oral Suspension 1oz. Grape BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00 300450122308

PRODUCT OFIRMEV (acetaminophen) injection, 1000mg/100ml, For Intravenous Use Only, Rx Only
CODE Lot V005710
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cadence Pharmaceuticals, San Diego, CA 92130-3583
Manufacturing Firm: Baxter Healthcare Corporation, Cleveland, Mississippi   
REASON FOR RECALL Presence of Particulate Matter
 
PRODUCT Cricothyroidotomy Convenience Kit (Crickit) 1) Crickit Product Code10-0017; Crickit is found inside the affected lot numbers of Medic Trauma Pack Kit: 2) BLK/Black: Part number 80-0070; 3) ODG/Green: Part number: 80-0071; 4) COY/Tan: Part number 80-0072; and 5) DUC/Camouflage: Part number 80-0096; as one of the components. 
CODE
1) Lot numbers: 21096, Exp. 03/14; 21420, Exp. 04/14; 21421, Exp.05/14; 21422, Exp. 05/14; 21423, Exp. 06/14; 21424, Exp. 06/14; 21910, Exp. 08/14; 21911, Exp. 08/14; 21912, Exp. 09/14; 21913, Exp. 09/14; 22151, Exp. 10/14; 22152, Exp. 11/14; 22289, Exp. 12/14; 22290, Exp. 12/14; 22344, Exp. 01/15; 22345, Exp. 01/15; 22346, Exp. 03/13; 22347, Exp. 03/13; 22725, Exp. 09/12; 22726, Exp. 09/12; 22727, Exp. 09/12; 22728, Exp. 09/12; 22946, Exp. 01/13; 22947, Exp. 01/13; 22948, Exp. 01/13; 22949, Exp. 01/13;
2) Lot numbers: 80-0070093009, 80-0070092810, 80-0070092210, 80-0070080609, 80-0070072810, 80-0070072710, 80-0070071510, 80-0070070710, 80-0070063009, 80-0070061710, 80-0070060110, 80-0070050409, 80-0070040910, 80-0070032211SX, 80-0070031210, 80-0070022211X, 80-0070021810, 80-0070020910, 80-0070012510, 80-0070012210, 80-0070011310, 80-0070120910, 80-0070120710, 80-0070112309, 80-0070111210, 80-0070102910, 80-0070102810, 80-0070102210, 80-0070101310 & 80-0070100810, Exp. 09/15;
3) Lot numbers: 80-0071092909, 80-0071090910, 80-0071090109, 80-0071072710, 80-0071071310, 80-0071041411SX, 80-0071012810, 80-0071012510, 80-0071120910 & 80-0071102910, Exp. 09/15;
4) Lot numbers: 80-072092909, 80-0072092710, 80-0072090810, 80-0072090109, 80-0072083109, 80-0072082310, 80-0072081109, 80-0072081009, 80-0072080709, 80-0072050710, 80-0072050409, 80-0072042110, 80-0072041510, 80-0072041410, 80-0072031710, 80-0072012910, 80-0072012810, 80-0072012010, 80-0072110810, 80-0072101210 & 80-0072100410, Exp. 09/15;  
5) Lot numbers: 80-0096061710, 80-0096050409, 80-0096041610, 80-0096031810, 80-0096012910, 80-0096012810, 80-0096012510, 80-0096010710, 80-0096120910, 80-0096120909, 80-0096112409, 80-0096110810, 80-0096101509, 80-0096101210 & 80-0096100410: Exp. 09/15).
RECALLING FIRM/MANUFACTURER North American Rescue, Greer, SC, 
REASON Microbial Contamination of Non-Sterile Products: The Kit contains Povidone Iodine Prep Pads that are being recalled by the Triad Group because they were found to be contaminated with the bacteria, Elizabethkingia meningoseptica.
VOLUME OF PRODUCT IN COMMERCE 26,000 kits
DISTRIBUTION Nationwide and Internationally
 
PRODUCT FLUDARA (fludarabine phosphate) for injection, 50 mg, Single Dose Vial, For Intravenous Use Only, Rx only. NDC Number 50419-511-06. 
CODE Lot Number 2020898 (Expiry Date June 2013)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genzyme Corp, Cambridge, MA, 
Manufacturer: Ben Venue Laboratories Inc., Bedford, OH. 
REASON Lack of assurance of sterility: Based on joint FDA/EMA inspection conducted at the manufacturer Ben Venue Laboratories in Bedford, Ohio, in November 2011, and the GMP deficiencies identified.
VOLUME OF PRODUCT IN COMMERCE 1876 packs (9380 vials)
DISTRIBUTION Nationwide

WEEK ENDING FEBRUARY 11

Regeneca, Inc. Issues A  Recall Of A Specific Lot Of RegenArouse  

Regeneca, Inc. is recalling RegenArouse, Lot Number 130100, because  lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

Regeneca, Inc. has distributed RegenArouse via sales made over the internet to consumers in the United States of America and Puerto Rico between November 29, 2011 and February 10, 2012.

RegenArouse, Lot Number 130100, is a pink capsule sold individually in foil packets, with the expiration date of 12/5/2013 and a UPC code of 816860010079. Regeneca, Inc. had this specific lot of RegenArouse capsules tested at a testing facility and had received a report indicating that no PDE-5 inhibitors or any of their analogues were detected in the capsules. 

Regeneca, Inc. advises any customers in possession of the RegenArouse product matching the lot number above to return any unused product for an exchange, or a full refund, to the company directly. 

Customers can call (800) 690-6958 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process.

Wholistic Herbs, Inc. Recalls "Koff & Kold" and "Kold Sore" Because Of Possible Health Risk

Wholistic Herbs Inc. of Dallas, TX, is recalling all quantities of the following two, 1 fl. oz. spray products distributed from March 2009 through February 2012. Products intended for use in the eye that are non-sterile have the potential to cause eye infections, which may be sight threatening. Also, nasal solutions that are not sterile could lead to a respiratory infection.

"Koff & Kold" and "Kold Sore" were distributed throughout the Unites States to retail stores located in Texas, California, Washington, Virginia, New Jersey, New York, Maryland, Illinois, Georgia, Nevada, Arizona, North Carolina, South Carolina, and Florida. The products were also distributed through acupuncture clinics and the firm’s website at www.naturalapothecary.com.

"Koff & Kold" and "Kold Sore" are packaged in white plastic 1 fluid oz spray bottles which contain a product insert inside of the clear plastic lid. The product insert provides usage instructions to customers. The products are identified with a "USE BY" date on the bottom of the bottle. All used by dates are being recalled.

Consumers who have purchased "Koff & Kold" and "Kold Sore" are urged to discontinue use of the product and return the product to the place of purchase for a full refund. 

Consumers with questions may contact the company Monday through Friday 9:00am to 5:00pm CST at 214-691-3210. 

PRODUCT Fludeoxyglucose F 18 Injection, 20-300mCi/mL, Diagnostic, IV, Multiple-Dose Vial, Rx only, NDC 52768-001-50
CODE 6509, Expiration Date: 6:15 pm on 27 December 2011
RECALLING FIRM/MANUFACTURER Precision Nuclear of Virginia, Salem, VA 24153-6427
REASON FOR RECALL Impurities/Degradation Product: out-of-specification (OOS) results for Acetonitrile, K222 and Radiochemical purity
 
PRODUCT
1) LO/OVRAL-28 (norgestrel and ethinyl estradiol tablets), 21 white tablets each containing 0.3 mg norgestrel with 0.03 mg ethinyl estradiol, and 7 pink inert tablets, Package contains 6 Pilpak Dispensers of 28 Tablets each, Rx Only, NDC 24090-801-84. 
 
2) Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg Tablets --- 21 white tablets, each containing 0.3 mg norgestrel with 0.03 mg ethinyl estradiol, and 7 pink inert tablets, Package contains 6 Pilpak Dispensers of 28 Tablets each, Rx Only, NDC 24090-961-84. 
CODE
1) Lot Expiration; E15678 08/31/2013; E15679 08/31/2013; E15686 08/31/2013; E15687 01/31/2014; E15690 01/31/2014; E15698 01/31/2014; E15700 02/28/2014; E80434 07/31/2013; E80438 08/31/2013; F36908 02/28/2014; F36909 02/28/2014; F43915 03/31/2014; F43926 03/31/2014; F43927 03/31/2014;
 
2) Lot Expiration; E15677 08/31/2013; E15704 01/31/2014; E15706 01/31/2014; E80440 08/31/2013; F16388 01/31/2014; F16390 02/28/2014; F22132 02/28/2014; F31330 02/28/2014; F36911 03/31/2014; F36913 03/31/2014; F43924 03/31/2014; F43925 03/31/2014; F43934 03/31/2014; F53238 03/31/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, 
Manufacturer: Pfizer, Inc., Rouses Point, NY. 
REASON Contraceptive Tablets Out of Sequence: some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence.
VOLUME OF PRODUCT IN COMMERCE 171,928 Packages
DISTRIBUTION Nationwide

 

PRODUCT
1) 15% Minoxidil for Men, Enhanced with Azelaic 5%, Topical Hair Regrowth Formula, 2 fl oz 60 mL bottles. 
 
2) 10% Minoxidil for Men, Enhanced with Azelaic 5%, Topical Hair Re-growth Formula, 2 fl oz 60 mL glass bottle. 
 
3) 5% Minoxidil for Men, Enhanced with Azelaic 5% Topical Hair Regrowth Formula, 2 fl oz 60 mL glass bottle. 
 
4) 3% Minoxidil for Women, Enhances with Azelaic 1.5%; Hair Regrowth Topical, 2 fl oz 60 mL glass bottles, 
 
5) Hair Regrowth Shampoo Enhanced with Ketoconazole and Salicylic Acid, 6 fl oz. 180 mL, plastic bottle, 
CODE
1) All expiration dates up to Oct. 2013;
2) All expiration dates up to Oct. 2013;
3) All expiration dates up to Sept. 2014;
4) All expiration dates up to Nov. 2013;
5) All expiration dates up to Dec. 2013.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perfect Image Solutions LLC, Roseville, CA, 
Manufacturer: Custom Manufacturing Corp, Medley, FL. 
REASON Marketed Without an Approved NDA/ANDA: products are unapproved drugs.
VOLUME OF PRODUCT IN COMMERCE 109,000 units
DISTRIBUTION Nationwide, Macau, Russia, Dubai, Hong Kong and Taiwan

 

PRODUCT Azithromycin 250 mg tablets, 1 card x 6 Tablets, Rx only, NDC 0093-7146-18 (Teva Pharmaceuticals), A-S Product No. 5755-0. 
CODE Lot 1318262, Exp 04/14
RECALLING FIRM/MANUFACTURER
Recalling Firm: A-S Medication Solutions LLC, Libertyville, IL, 
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. 
REASON Labeling: Label with Incorrect Expiration Date.
VOLUME OF PRODUCT IN COMMERCE 720 boxes
DISTRIBUTION Nationwide

 

PRODUCT
1) TestaEdge Cream For Men, Homeopathic, packaged in 4-oz. jars, Paraben Free, NDC # 57520-0688-1, UPC Code 898849001001. ;
 
2) TestaEdge Cream For Women, Homeopathic, packaged in 4-oz. jars, Paraben Free, NDC # 57520-0907-1, UPC Code 898849001018. 
 
3) Pain Relief Cream, Homeopathic, packaged in 4-oz jars, Paraben Free, NDC # 57520-0689-1, UPC Code 898849001025. 
 
4) Libido Edge Labs Total GH Cream, Homeopathic, packaged in 4-oz. jars, Paraben free, NDC # 57520-0690-1, UPC Code 898849001278. 
CODE
1) Lot G7519;
2) Lot G7518;
3) Lot G7437;
4) Lot G7438
RECALLING FIRM/MANUFACTURER Apotheca Inc, Woodbine, IA, 
REASON Microbial Contamination of Non-Sterile Products:  presence of Enterobacter gergoviae and Pseudomonas monteilii/plecoglossicida.
VOLUME OF PRODUCT IN COMMERCE 3,490 Jars
DISTRIBUTION OH
 
PRODUCT CHLORHEXIDINE, (0.12% CHLORHEXIDINE GLUCONATE), ALCOHOL FREE, ORAL RINSE, Mint, Rx Only, Net WT 16 fl. oz. (473 ml), Gelato, Manufactured by: Deepak Products, LLC, Miami, FL -- NDC 068400-500-16 ----- ALSO LABELED AS CHLORHEXIDINE, (0.12% CHLORHEXIDINE GLUCONATE), ALCOHOL FREE, ORAL RINSE, Mint, Rx Only, Net WT 16 fl. oz. (473 ml), Gibson Healthcare, Distributed Exclusively by: Benco Dental, Pittsburgh, PA --- NDC 066975-500-16, and ORA-RINZ, (0.12% CHLORHEXIDINE GLUCONATE), ALCOHOL FREE, ORAL RINSE, Mint, Rx Only, Net WT 16 fl. oz. (473 ml) Manufactured for: Pearson Dental Supply Inc. Sylmar, CA 91342 USA, NDC 068400-155-16. .
CODE
Lot #’s: 110226A, 110420F, 110509, 110721D, 110603D, 110721D, 110901, 111005A, 110420F, 110314E, 110622B, 110811, 110222A, 110222B, 110223, 110223A, 110223B, 110224, 110224A, 110224B, 110225B, 110225C, 110225D, 110225F, 110301B, 110301D, 110302B, 110302C, 110303A, 110303B, 110413C, 110413D, 110415B, 110414A, 110414B, 110414C, 110415, 110415A, 110425B,110425c, 110425D, 110426B, 110426C, 110426D, 110427B, 110427C, 110429C, 110606A, 110607B, 110607C, 110607D, 110622C, 110623, 110623B, 110623F, 110629B, 110629C, 110629D, 110630A, 110630B, 110630C, 110803A, 110805, 110805A, 110805B, 110808C, 110818A, 110823A, 110901
RECALLING FIRM/MANUFACTURER Deepak Products, Inc., Miami, FL,
REASON CGMP Deviations.
VOLUME OF PRODUCT IN COMMERCE 32,083 bottles
DISTRIBUTION Nationwide, and El Salvador, Dominican Republic, and Honduras

 

PRODUCT Prosed DS Tablets (Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, and Hyoscyamine Sulfate 0.12 mg), 100 count bottle, Rx Only, NDC 55566-8101-1.
CODE Lot # 101329 Exp Date 04/12; and Lot # 102285 Exp Date 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals Inc., Parsippany, NJ, 
Manufacturer: Contract Pharmacal Corp., Hauppauge, NY. 
REASON Subpotent (multiple ingredient drug): hyoscyamine sulfate component.
VOLUME OF PRODUCT IN COMMERCE 51,198 bottles
DISTRIBUTION Nationwide

 

PRODUCT Xanax, alprazolam tablets, USP, 0.5 mg, 100 Tablets, Rx only, NDC 0009-0055-01. 
CODE Lot: C081196
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Us Pharmaceutical Group, New York, NY,
Manufacturing Firm : Pfizer Pharmaceuticals LLC, Caguas, PR. 
REASON Failed USP Dissolution Test Requirements: Stability testing yielded an out-of-specification result for assay at the 36 month stability testing timepoint
VOLUME OF PRODUCT IN COMMERCE 36,129 bottles
DISTRIBUTION Nationwide and PR

WEEK ENDING FEBRUARY 4

Healthy People Co. Issues a Recall of Specific Lots of the Dietary Supplements 

Healthy People Co. is recalling the company’s dietary supplements sold under the brand names Healthy People Co. specific to the following Lot Numbers:

Product Name Packaging Lots
Mince Belle Dietary Supplement 30 Capsules HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021; UPC7503013203305
PERFECT Men Dietary Supplement 30 Capsules HPCPM/002; UPC7503013203190
EVERLAX Dietary Supplement 30 Capsules HPCEX/074, HPCEX/076, HPCEX/072; UPC7503013203046
EVER Slim Dietary Supplement 30 Capsules HPCES-079, HPCES-070, HPCES-071; UPC7503013203053
Herbal Drink Acai-man Mangosteen Dietary Supplement 16.6 fl oz HPJAC/004 : UPC7503013203015
EVER SLIM Shake Mix Dietary Supplement Strawberry 17.6 oz HPESSF/168: UPC7503013203084
EVER SLIM Shake Mix Dietary Supplement Chocolate 17.6 oz HPESSC/061: UPC7503013203077

Healthy People Co. is conducting a because of the presence of Sibutramine and Tadalafil, making these products unapproved new drugs.

Healthy People Co. advises any customers in possession of the products listed above with matching the lot numbers to return any unused product for a full refund to the company directly. Customers can call 626-939-4132 M-F 9am-5pm (PST) for instructions on the return and refund process.

These products were sold, or distributed at our store located at: 13105 Ramona Blvd Ste F, Irwindale, CA, 91706, and can be returned, and exchanged at the same location.

PRODUCT Virility Max, 10 Capsules, Supplement Facts Serving Size 1 Capsule, Keep away from children, For mens use only, Contains 450 mg, Rowdy Lamb, Puncture vine, Ginnsue Herb, Aarons Rod, Matrimony Vine, Cocky Cinnamon. 
CODE Lot #: 10090571
RECALLING FIRM/MANUFACTURER
Recalling Firm: Keime, Inc., Boca Raton, FL,  
Manufacturer: ABCO Laboratories, Inc., Fairfield, CA. 
REASON Marketed Without an Approved NDA/ANDA: Product found to contain sulfoaildenafil and sulfosildenafil, analogues of sildenafil, the active ingredient in a FDA approved drug used to treat erectile dysfunction, making Virility Max an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE 944 bottles
DISTRIBUTION Nationwide
 
PRODUCT Medroxyprogesterone Acetate Injectable Suspension, USP 150 mg/mL, a) 1mL Vials  (NDC 0703-6801-01); b) box of 25 single dose vials (NDC 0703-6801-04); and c) 1mL Prefilled Syringes (NDC 0703-6811-21), Rx only, For IM Use Only. 
CODE
a) Lot #’s: 31310301B, exp 12/2011; 31310788B, exp 1/2012; 31311008B, exp 4/2012; b) Lot #’s: 31310787B, exp 1/2012; 31311357B, exp 4/2012 and c) Lot #’s: 31311217B, exp 2/2012; 31311219B, exp 2/2012; 31312156B, exp 4/2012; 31312300B, 4/2012
RECALLING FIRM/MANUFACTURE
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA.  
REASON Presence of Particulate Matter; presence of silicone particles.
VOLUME OF PRODUCT IN COMMERCE 229,470
DISTRIBUTION Nationwide and Puerto Rico

 

PRODUCT Amlodipine Tablets USP, 2.5 mg, Once-Daily, Qty 30 tablets per Unit Carton, Rx Only, NDC 76237-109-30. 
CODE Lot #: 0000000, Exp 00/00/0000
RECALLING FIRM/MANUFACTURER
Recalling Firm: McKesson Packaging Services, Concord, NC, 
Manufacturer: Omnicare Inc., Covington, KY. 
REASON Unit Dose Mispackaging; cartons labeled as Amlodipine Tablets, NDC 76237-109-30 actually contain blister packs of Lisinopril, NDC 76237-195-30.
VOLUME OF PRODUCT IN COMMERCE 4,584 Unit Cartons
DISTRIBUTION Nationwide

 

PRODUCT Equate Fiber Therapy, Sugar Free, Orange Flavor, 36.8 oz., packaged in plastic bottles, NDC 49035-066-48. 
CODE Codes: H16601X, H16602X, H16603X, H16604X, H16605X, H16606X, H16607X, H16608X, H16609X, H16610X, H16611X, H16612X, H16613X. All Exp. Date 08/2013
RECALLING FIRM/MANUFACTURE Konsyl Pharmaceuticals Inc., Easton, MD, 
REASON Labeling: Label lacks Warning; Warning advisory regarding phenylketonurics in the product is not stated on the label.
VOLUME OF PRODUCT IN COMMERCE 54,870 bottles
DISTRIBUTION IN

 

PRODUCT Alprazolam Tablets, USP, 2 mg, Rx only, a) NDC 0603-2130-21 (100-count bottle), b) NDC 0603-2130-28 (500-count bottle). 
CODE
a) Lot #: T025D10A, exp. 06/12; T026D10A, exp. 06/12; T023D10B, exp. 04/12; T024D10B, exp. 04/12; T182H10A, exp. 09/12; T185H10A, exp. 10/12; T020J10A, exp. 10/12; T021J10A, exp. 10/12; T003L10A, exp. 12/12; T178M10A, exp. 01/13; T179M10A, exp. 01/13; T202B11A, exp. 02/13; T239C11A, exp. 02/13; T025D11A, exp. 03/13; T024D11A, exp. 03/13; T026D11A, exp. 04/13; T027D11A, exp. 04/13; T019E11A, exp. 04/13; T020E11A, exp. 04/13; T021E11A, exp. 04/13; T021H11A, exp. 07/13; T017J11A, exp. 08/13; T016J11A, exp. 08/13; T020K11A, exp. 09/13; b) Lot #: T148M09A, exp. 12/11; T164M09A, exp. 12/11; T022D10A, exp. 04/12; T023D10A, exp. 04/12; T024D10A, exp. 04/12; T026D108B, exp. 06/12; T183H10B, exp. 10/12; T184H10A, exp. 10/12; T186H10A, exp. 10/12; T187H10A, exp. 10/12; T180M10A, exp. 01/13; T076B11A, exp. 02/13; T201B11A, exp. 02/13; T240C11A, exp. 02/13; T028D11A, exp. 04/13; T029D11A, exp. 03/13; T017E11A, exp. 05/13; T018E11A, exp. 03/13; T022H11A, exp. 07/13; T018J11A, exp. 08/13; T019K11A, exp. 09/13
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL, 
REASON Tablet Separation: Premature tablet breakage.
VOLUME OF PRODUCT IN COMMERCE 295,216 bottles
DISTRIBUTION Nationwide

 

PRODUCT CARDURA XL (doxazosin mesylate extended release tablets) 4 mg, 30 ct bottle, NDC 0049-2710-30, 
CODE Lot V101161, Exp. 04/12
RECALLING FIRM/MANUFACTURER Pfizer US Pharmaceutical Group, New York, NY, 
REASON Failed USP Dissolution Test Requirements: Stability testing yielded an out of specification result for an individual value at 8 hour dissolution.
VOLUME OF PRODUCT IN COMMERCE 12,521 bottles
DISTRIBUTION Nationwide and PR
 
PRODUCT Acetaminophen and Codeine Phosphate CIII Tablets USP 300 mg/60 mg, (Each tablet contains: Acetaminophen USP...300 mg and Codeine Phosphate USP...60 mg), 100 count bottles, Rx Only, NDC 0406-0485-01. 
CODE Lot number: 0485T81671, Expiration date: 10/2013
RECALLING FIRM/MANUFACTURE
Recalling Firm: Mallinckrodt Inc., Hazelwood, MO, 
Manufacturer: Mallinckrodt Inc., Hobart, NY. 
REASON Labeling: Incorrect or Missing Package Insert.
VOLUME OF PRODUCT IN COMMERCE 5280 bottles
DISTRIBUTION Nationwide and PR

Bedford Laboratories Recall Of Acetylcysteine Solution, USP, LOT 1877093

Bedford Laboratories™ is recalling:

Acetylcysteine Solution, USP, (Manufactured for Roxane Laboratories, Inc.) 20%, 30 mL per vial – NDC #0054-3026-02 – Lot 1877093 – Exp. Date June 2013

This recall was initiated after the discovery of a single visible glass particle in a vial within the lot listed above.

Patients that may have received product dispensed from this one lot should return the product to their pharmacist. Distributors/retailers that have not received a recall packet should contact GENCO Pharmaceutical Services, 6101 North 64th Street, Milwaukee, WI 53218.

For information regarding the recall process, call GENCO Pharmaceutical Services at 800-950-5479 and select menu option 1. For technical product information or to report a technical product complaint, call 800-962-8364 and select menu option 6.