NOVEMBER 2012

WEEK ENDING NOVEMBER 24

Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05, Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14 Class III Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution." Stat Rx USA
Drugs Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured for S.P. Richards Co., 6300 Highlands Pkwy., Smyma, GA 30082, UPC 0 35255 10477 7; b) Pro Chem Lemon Aid, Hand Sanitizing Wipes, 85-count premoistened wipes per bucket, 6 buckets per case, An exclusive product of: Pro Chem, Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004; c) Scrubs, Lemon Hand Sanitizer Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured in the U.S.A. by ITW Dymon, 805 E. Old 56 Highway, Olathe, KS 66061, UPC 7 64769 92991 9. Lot #: a) B26221, Exp 09/18/15; b) B94221, Exp 09/05/15; c) B94221, Exp 09/05/15 Class III CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt. ITW Dymon
Drugs All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com All lot codes Class II GMP Deviations New England Compounding Center
Drugs All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com All lot codes within expiry Class II Lack of assurance of sterility Ameridose LLC
Drugs All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com All lot codes within expiry Class II GMP deficiencies Ameridose LLC
Drugs Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30 Lot # A00984 Exp. 01/14 Class III Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules." Stat Rx USA

WEEK ENDING NOVEMBER 17

Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India Batch Number ZPSB11054-A Exp. 05/13 Class II Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg Aurobindo Pharma LTD
Drugs AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12030 7 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient. Valeant Pharmaceuticals
Drugs AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13548 6 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals
Drugs AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2. All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13546 2 Class III Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals

WEEK ENDING NOVEMBER 10

Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs X-ROCK For Men, Dietary Supplement, Directions: Take one capsule 1-2 hours prior to intimacy. Made In The USA, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792. UPC 0 00309 50792 7 All Lots Class I Marketed Without an Approved NDA/ANDA: Product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED). XRock Industries, LLC
Drugs Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus) Lot #, 2017619 (Bedford), Mfr Item # 0967-57-2017619, NDC, 55390-009-01, Exp. Date 11/2012; Lot# 2017620, Exp. Date 1/2013, NDC #55390-009-01; Lot #, 2017621 (Bedford), Mfr Item # 0967-57-2017621, NDC, 55390-009-01, Exp Date 01/2013; Lot #2038374, exp. 2/2013, NDC #55390-009-01; Lot #2038374A, exp. 2/2013, NDC #55390-826-01 Note: 2038374A (packaged using Novaplus labeling) is a sublot of 2038374 (packaged using Bedford labeling); Lot #, 2038375 (Bedford), Mfr Item # 0967-57-2038375, NDC, 55390-009-01, Exp Date 03/2013; Lot #, 2065418 (Bedford), Mfr Item # 0967-57-2065418, NDC, 55390-009-01, Exp Date 06/2013; Lot #, 2067176 (Bedford), Mfr Item # 0967-57-2067176, NDC, 55390-009-01, Exp Date, 06/2013; Lot #, 2067177 (Bedford), Mfr Item # 0967-57-2067177, NDC, 55390-009-01, Exp Date 06/2013 & Lot #, 2067178A (Novaplus), Mfr Item # 0967-57-2067178A, NDC, 55390-826-01, Exp Date, 06/2013. Class II Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample Ben Venue Laboratories Inc
Drugs X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, FL, Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida All Lots All codes. Class I Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil. Coral Rock Man, Inc.
Drugs Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066 All Lots All codes. Class I Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil. Coral Rock Man, Inc.
Drugs UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403 Batch 1782-01059, 2072-01059, and 2082-01195 Class II Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. DermaCare, Inc.
Drugs UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403 Batch 2082-01085, 1852-01085, 2082-01213, 2152-01261, and 1782-01084 Class II Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. DermaCare, Inc.

WEEK ENDING NOVEMBER 3

Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit). Lot 12720LL, Exp 12/01/13 Class I Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume. Hospira Inc.
Drugs Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA and AstraZeneca Pharmaceuticals LP, Wilmington DE 19850. Lot # 1J6024PA , 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13 Class II Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly. Bristol-myers Squibb Company
Drugs Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7 Tablets per Carton, 5 mg/500 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA and AstraZeneca Pharmaceuticals LP, Wilmington DE 19850. Lot # 1J6024PA, 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13 Class II Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly. Bristol-myers Squibb Company
Drugs BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, NY 11967 Distributed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA Made in USA NDC 0015-3012-18 NDC 0015-3012-60 Kit/Vial Lot #: (9L7003A/1803607), Exp 11/12; (9H4209A/1803608), Exp 01/13; (9H4211A/1843251), Exp 02/13; (0B7004A/1843251), Exp 04/13; (0B7005A/2011804), (0E7004A/2011804), Exp 05/13; (0E7006A/2055384), Exp 09/13; (0J7007A/2064024), (1A7005A/2064024), Exp 01/14; (1C7006A/2106210), Exp 04/14 Class I Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot. Bristol-myers Squibb Company
Drugs Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA *** Lot A 303M, Exp. June 2014 Class II Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine. Mylan Pharmaceuticals Inc.
Drugs Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, KS 06106, UPC 0-70038-63439-3 Lot 16273, Exp 06/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895 www.cvs.com UPC 0-50428-07739-9 Lots 16273, 16274, Exp 06/15; 16463, Exp 07/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 68163-119-60, UPC 6-81131-77922-7. Item Number: 4091097; Lots 15952, 16271, 16274, 16425, Exp 06/15; 16434, 16435, 16436, 16459, 16461, 16462,16465, Exp 07/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1. CIN 3510963; Lots 16273,16274, Exp 06/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA, NDC 11673-059-87, UPC 3-68163-11926-8. Item 119160TGT; Lots15952, Exp 06/15; 16459, 16460, 16463, Exp 07/15; 16475, Exp 08/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement, a)160 capsules per bottle (item #503663), and b) 320 capsules per bottle (Item #586143), Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616, www.walgreens.com, a) UPC 3-11917-08151-9, b) UPC 3-11917-07658-4 Lots a) 15952, 16270,16425, Exp 06/15; b)16459, 16466, 16467, Exp 07/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary Fiber Supplement, 240 Capsules per bottle, Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616 www.walgreens.com, NDC 0363-0128-24, UPC 3-11917-07656-0. Item 586144, Lots 15085, Exp 04/15; 15086, 15087, Exp 08/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2. Lot 16470, Exp 08/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bottle, Distributed by: SAM'S West, Inc., Bentonville, AR 72716, UPC 0-78742-00524-9. Lots 16273, Exp 06/15; 16460, 16464, 16466, 16468, 16469, Exp 07/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves Constipation, Restores Regularity, 160 Capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431, UPC0-40986-01703-2 Lot 16470, Exp 08/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL, UPC 8-40986-01987-6 Lot 15087, Exp 08/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1. Lots: 16274, Exp 06/15; 16471 Exp 08/15 Class II Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. Raritan Pharmaceuticals, Inc.
Drugs Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), 50 pre-moistened Wipes, Manufactured by: ABC Compounding Co., Inc., P.O. Box 16247, Atlanta, GA 30321. Lot #3220 Class III Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover). Abc Compounding Company Inc
Drugs Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21. Lot C1130511A, Exp 5/13 Class II Tablet Separation: Possibility of cracked or split coating on the tablets. Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Drugs Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.; NDC 52544-383-28. Lot #: 515622AA, 515623AA, and 515623BA, Exp 09/30/13 Class II Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). Watson Laboratories Inc
Drugs Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc., Parsippany, NJ 07054 USA; NDC 52544-949-28. Lot #: 517921AA, 517921AB, 517922AA, 517922AB, 517923AA, 517923AB, Exp 03/31/14 Class II Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). Watson Laboratories Inc
Drugs Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA; NDC 52544-953-28. Lot #: 514767AA, Exp 03/31/14 Class II Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). Watson Laboratories Inc
Drugs Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.; NDC 52544-554-28. Lot # 512642B, Exp 08/31/13 Class II Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). Watson Laboratories Inc
Drugs Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Pharma, Inc., A subsidiary of Watson Pharmaceuticals, Inc., Corona, CA 92880 USA; NDC 52544-552-28. Lot #: 514743AB, Exp 09/30/13 Class II Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). Watson Laboratories Inc