APRIL 2008

WEEK ENDING APRIL 5

PRODUCT
a) Perphenazine Tablets, USP, 2 mg, Rx only, 100 tablets, NDC 0603-5090-21, ANDA 40-226. 
b) Perphenazine Tablets, USP, 4 mg, Rx only, 100 tablets, NDC 0603-5091-21, ANDA 40-226. 
CODE
a) Lot No. T002G07A
b) Lot No. T048F07A
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals LLC, Huntsville, AL
REASON Tablet separation; cracking and splitting of tablets
VOLUME OF PRODUCT IN COMMERCE 28,398 units
DISTRIBUTION Nationwide

PRODUCT
a) Actavis brand Fentanyl Transdermal System, CII, 25 mcg/hr., Rx, NDC 67767-120-18.Each box of 5 pouches contains pouches labeled Abrika Pharmaceuticals Fentanyl     Transdermal System CII, NDC 67767-120-08, 
b) Actavis brand Fentanyl Transdermal System, CII, 50 mcg/hr., Rx. Each box of 5 pouches contains pouches labeled Abrika Pharmaceuticals Fentanyl Transdermal System CII, NDC 67767-121-08, 
c) Actavis brand Fentanyl Transdermal System, CII, 75 mcg/hr., Rx, NDC 67767-122-18. Each box of 5 pouches contains pouches labeled Abrika Pharmaceuticals Fentanyl Transdermal System CII, NDC 67767-122-08, 
d) Actavis brand Fentanyl Transdermal System, CII, 100 mcg/hr., Rx, NDC 67767-123- 18. Each box of 5 pouches contains pouches labeled Abrika Pharmaceuticals Fentanyl Transdermal System CII, NDC 67767-123-08,
CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Actavis Elizabeth LLC, Elizabeth, NJ, 
Manufacturer: Corium International, Inc., Grand Rapids, MI. 
REASON Defective Delivery System; the patches may leak, resulting in the potential for overdosing.
VOLUME OF PRODUCT IN COMMERCE 590224 boxes of 5 patches each
DISTRIBUTION Nationwide

PRODUCT Chigarid External Analgesic, Camphor 2.8%, Phenol 1.5% and Menthol 0.1%, 0.5 FL. OZ. bottles, For the temporary relief of itching & pain associated with insect bites, 
CODE All lots of product are being recalled. UPC code 71053244420
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richard E. Colgin I, Ltd., Dallas, TX, 
Manufacturer: Trinkote Industrial Finishes, Inc., Fort Worth, TX. REASON Defective container; product has the potential to evaporate over time
VOLUME OF PRODUCT IN COMMERCE 84,672 units (1/2-oz. bottles)
DISTRIBUTION Nationwide

PRODUCT Cromolyn Sodium Inhalation Solution USP 20 mg/2 mL Unit Dose Vials, 60 and 120 count boxes, Rx only, Steri-Neb brand of Sterile Unit Dose Vials, Not For Injection Aqueous Solution for Nebulization, Preservative Free, For Oral Inhalation Use Only, 
CODE
60 count boxes; NDC number 0172-6406-49. Lot numbers W19522 exp 01/2010, W19661 exp 02/2010, W19821 exp 03/2010, W19841 exp 03/2010, W20101 exp 05/2010, and W20161 exp 05/2010 120 count boxes; NDC number 0172-6406-59. Lot numbers W19111 exp 11/2009 and W19811 exp 02/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL,
Manufacturer: IVAX Pharmaceuticals UK Limited, Cheshire  WA7 3FA. UK. 
REASON Failed pH Specification
VOLUME OF PRODUCT IN COMMERCE 30,088 units
DISTRIBUTION Nationwide

PRODUCT Hydrochlorothiazide Tablets USP 25mg, 10 count bags, Rx only, 
CODE NDA# 55154-5841-0; Batch# M083850; Lot #CDV89AB
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Zanesville, OH, 
Manufacturer: IVAX Ireland Pharmaceuticals, Waterford, Ireland. REASON Incorrect Expiration Date; bag label bears an incorrect expiration date of 12/09. The unit dose blister inside the bag label bears the correct expiration date of 12/08
VOLUME OF PRODUCT IN COMMERCE 1680 bags of 10/25 mg tablets
DISTRIBUTION Nationwide

PRODUCT
a) Children's Chewable Aspirin, 81 mg each, Pain Reliever/Fever Reducer, ORANGE FLAVOR, 36 Tablets, NDC 0603-0024-36, 

b) Acetaminophen 325 mg/Phenylephrine HCl 5 mg/Chlorpheniramine Maleate 2 mg tablets, OTC, packed in bulk, net wt. 15.00 kg, 
c) Health A2Z Extra Strength PAIN RELIEF PM, Pain Reliever/Sleep Aid, Acetaminophen 500 mg and Diphenhydramine HCl 25 mg, 24 Caplets per bottle and in bulk, OTC, 
CODE
a) Lot 7J16471 (exp. 10/2010)
b) Bulk Lot 7K27541 (exp. 10/08)
c) Lot 6C02096 (exp. 3/2009) and bulk lot 6C02097 (exp. 3/2009)
RECALLING FIRM/MANUFACTURER A & Z Pharmaceutical, Inc., Hauppauge, NY, 
REASON Failure to validate manufacturing process; the products were re-worked without proper validation
VOLUME OF PRODUCT IN COMMERCE
(1) Lot 7J16471: 2088 bottles; (2) Lot 7K27541: 1,164,654 bulk tablets; (3) Lot 6C02096: 29,571bottles; Lot 6C02097: 744,290 bulk tablets
DISTRIBUTION Nationwide

 

PRODUCT Rantidine Syrup (Ranitidine Oral Solution, USP); 15 mg/mL (75mg/5mL) One Pint (473 mL). 
CODE
Lot # 115600, Exp. Feb 08; Lot # 115800, Exp. Feb 08; Lot # 116000, Exp. Mar. 08; Lot # 116400, Exp. Mar. 08; Lot # 118000, Exp. Apr. 08; Lot # 118300, Exp. Mar. 08; Lot # 118500, Exp. Apr. 08; Lot # 118700, Exp May 08; Lot # 119400, Exp May 08; Lot # 121700, Exp. Jun 08; Lot # 121900, Exp Jun 08; Lot # 122500, Exp May 08; Lot # 122900, Exp Jul 08; Lot # 124300, Exp Aug 08; Lot # 127000, Exp Sep 08; Lot # 129300, Exp. Oct 08; Lot # 131200, Exp. Nov. 08; Lot # 132600, Exp Oct 08; Lot # 136300, Exp. Dec. 08.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Actavis Elizabeth LLC, Elizabeth, NJ, 
Manufacturer: VistaPharm, Inc., Largo, FL. F
REASON Failed Related Compound Specification (9 month stability)
VOLUME OF PRODUCT IN COMMERCE 284, 196 bottles (27,204 bottles on hold at distribution center)
DISTRIBUTION Nationwide and Puerto Rico

WEEK ENDING APRIL 12

PRODUCT Fentanyl Transdermal System, 75 mcg/h, Each transdermal system contains; 7.5 mg fentanyl and 0.3 mL alcohol USP, Rx Only, NDC 0591-3213-54, UPC 305913213548. Packaged in boxes of five pouches with NDC 0591-3213-72, UPC 305913213722, 
CODE Lot No. 92461681
RECALLING FIRM/MANUFACTURER Watson Laboratories, Inc., Salt Lake City, UT
REASON Superpotent; 6 month stability.
VOLUME OF PRODUCT IN COMMERCE 28416 cartons
DISTRIBUTION Nationwide

Herbal Science International, Inc. Recalls Twelve Dietary Herbal Supplements Nationwide 

Herbal Science International, Inc. (AKA Jen-On Herbal Science International, Inc.) is recalling twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers.

The company is recalling nine products that contain ephedra, a source of ephedrine alkaloids, as an ingredient sold labeled under the following brands:

Wu Yao Shun Qi San
Qing Bi Tang (Nasal Cleanser)
Zhong Fong Huo Luo Wan (Stroke Revito Formula)
Xiao Qing Long Tang (Little Green Dragon)
Ding Chuan Tang
Xiao Xu Ming Tang
Feng Shi Zhi Tong Wan (Joint Relief)
Guo Min Bi Yan Wan
Fang Feng Tong Sheng San

Herbal Science International, Inc. is also recalling Tou Tong San (Headache Formula) and Du Huo Ji Sheng Tang (Du Huo Joint Relief), two products containing aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. This chemical can cause serious kidney damage and the use of products that contain aristolochic acid has been associated with several occurrences of kidney failure. These products have also been linked to an increased risk of kidney cancer in people who have consumed them.

Finally, the company is recalling Seng Jong Tzu Tong Tan, a product that contains human placenta. Human placenta may transmit disease and dietary supplements that contain it may not be lawfully marketed in the United States.

All of the twelve products under recall are packed in white plastic bottles of 100 capsules. All lots are covered in this recall action. These products have been sold nationwide in herbal stores, by acupuncturists and on the internet.

Consumers who have purchased these products should immediately discontinue their use and return them to the place of purchase for a full refund. Consumers with questions may contact the company at (626) 333-9998. Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional.

WEEK ENDING APRIL 19

PRODUCT Sertraline Hydrochloride Oral Concentrate, 20 mg/mL, 60 mL bottle, RX only, NDC 0054-0082-46, 

CODE Lots: 657694A, exp. Sep 08; 657695A, exp. Sep 08; 658085A exp. Jan 09
RECALLING FIRM/MANUFACTURER Boehringer Ingelheim Roxane Incorporated, Columbus, OH, 
REASON Product does not meet degradation specifications over shelf life.
VOLUME OF PRODUCT IN COMMERCE 21,822 Units
DISTRIBUTION Nationwide

PRODUCT ACT Restoring Anticavity Fluoride Mouthwash (sodium fluoride 0.05%), Cool Splash Spearmint flavor, 18 fl oz. 
CODE Lot: RTP0078G, exp. 01/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Chattem Inc., Chattanooga, TN, 
Manufacturer: Access Business Group Llc, Ada, MI. 
REASON Some bottles are mislabeled as mint flavor instead of spearmint flavor and do not declare the presence of color ingredients green 3 and yellow 10.
VOLUME OF PRODUCT IN COMMERCE 26,976 units
DISTRIBUTION Nationwide

WEEK ENDING APRIL 26

PRODUCT
a) The finished product label stated in its entirety "Eye Drops Caution: Do Not Use
With Implants" in .22 oz bottle. This is a light amber colored liquid in a plastic
dropper bottle, 
b) The finished product label states in its entirety: "Eye/Ear Wash". It is light amber
colored liquid in a plastic dropper bottle,
CODE No codes
RECALLING FIRM/MANUFACTURER Nucel Lab Inc., Idaho Falls, ID
REASONNNon Sterile
VOLUME OF PRODUCT IN COMMERCE 500 bottles
DISTRIBUTION ID, IN

PRODUCT Cefdinir for Oral Suspension, 3 gm, 250 mg/5mL after reconstitution, 60 mL when reconstituted, Rx only, NDC 0093-4137-64, 
CODE Lot 72225, exp. 03/31/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, 
Manufacturer: Teva Pharmaceuticals USA, Inc., Fairfield, NJ. 
REASON Product failed assay specification on 10th day of reconstitution when tested at 9 months.
VOLUME OF PRODUCT IN COMMERCE 21,525 bottles
DISTRIBUTION TN

Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories DigitekŪ (digoxin tablets, USP) 

Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a recall of DigitekŪ (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.

The recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.

DigitekŪ is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.

Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.

Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found at http://www.actavis.us/.

Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers.