Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-633-2013 | 03-20-2013 | Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Clinical Specialties Compounding Pharmacy / N/A | Class II | Terminated |
| D-664-2013 | 03-20-2013 | Test Cyp 10 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 7ml | Class II | Terminated |
| D-674-2013 | 03-20-2013 | Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 65ml total | Class II | Terminated |
| D-677-2013 | 03-20-2013 | Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 13ml total | Class II | Terminated |
| D-670-2013 | 03-20-2013 | Test cyp 25 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 12ml | Class II | Terminated |
| D-665-2013 | 03-20-2013 | Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 219ml total | Class II | Terminated |
| D-672-2013 | 03-20-2013 | Test cyp 35 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 12ml | Class II | Terminated |
| D-642-2013 | 03-20-2013 | Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 35ml total | Class II | Terminated |
| D-668-2013 | 03-20-2013 | Test cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 4ml | Class II | Terminated |
| D-635-2013 | 03-20-2013 | Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Clinical Specialties Compounding Pharmacy / 80 ml total | Class II | Terminated |
| D-652-2013 | 03-20-2013 | Medroxyprogesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 2ml total | Class II | Terminated |
| D-663-2013 | 03-20-2013 | Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 116ml total | Class II | Terminated |
| D-678-2013 | 03-20-2013 | Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 11ml | Class II | Terminated |
| D-675-2013 | 03-20-2013 | Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 13ml | Class II | Terminated |
| D-649-2013 | 03-20-2013 | Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / N/A | Class II | Terminated |
| D-658-2013 | 03-20-2013 | Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 378ml total | Class II | Terminated |
| D-640-2013 | 03-20-2013 | Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 17ml total | Class II | Terminated |
| D-655-2013 | 03-20-2013 | Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 95ml total | Class II | Terminated |
| D-637-2013 | 03-20-2013 | Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Clinical Specialties Compounding Pharmacy / 87 ml total | Class II | Terminated |
| D-657-2013 | 03-20-2013 | Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 6ml total | Class II | Terminated |
| D-669-2013 | 03-20-2013 | Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 10ml total | Class II | Terminated |
| D-632-2013 | 03-20-2013 | Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 300ml | Class II | Terminated |
| D-661-2013 | 03-20-2013 | Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 60ml | Class II | Terminated |
| D-659-2013 | 03-20-2013 | Ophthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 360ml total | Class II | Terminated |
| D-644-2013 | 03-20-2013 | HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / N/A | Class II | Terminated |
| D-662-2013 | 03-20-2013 | Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 637ml total | Class II | Terminated |
| D-578-2013 | 03-19-2013 | Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01 | CGMP Deviation; cotton coil is missing in some packaged bottles | Teva Pharmaceuticals USA, Inc. / 68,322 bottles | Class III | Terminated |
| D-238-2013 | 03-19-2013 | Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15. Package NDCs: 55111-179-30; 55111-179-15; 55111-179-03; 55111-179-10; 55111-180-30; 55111-180-15; 55111-180-03; 55111-180-10 | Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details. | Dr. Reddy'S Laboratories / 117,546 bottles | Class III | Terminated |
| D-343-2014 | 03-18-2013 | Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216 | SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets. | Boehringer Ingelheim Roxane Inc / 8,550 cartons and bottles | Class III | Terminated |
| D-310-2013 | 03-18-2013 | Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054 | Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine. | Reckitt Benckiser Inc / 27,718 cases 16 count and 7,551 cases 576 count | Class III | Terminated |
| D-306-2013 | 03-18-2013 | Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942. | Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013. | West-ward Pharmaceutical Corp. / 1,258 bottles | Class II | Terminated |
| D-242-2013 | 03-18-2013 | Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01. | Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months. | West-ward Pharmaceutical Corp. / 3, 061 bottles | Class II | Terminated |
| D-499-2013 | 03-18-2013 | Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA | Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing | Physicians Total Care, Inc. / 6 cards of 28 tablets | Class III | Terminated |
| D-806-2013 | 03-18-2013 | Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0. | Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution. | Apotex Corp. / 37,303 vials | Class I | Terminated |
| D-311-2013 | 03-16-2013 | "Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015. | Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination. | Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals / 13,369 bottles (12oz), 2607 bottles (26oz) | Class II | Terminated |
| D-681-2013 | 03-15-2013 | Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67 Package NDCs: 0555-9014-79; 0555-9014-67 | Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing | Teva Pharmaceuticals USA, Inc. / 148,785 blister packs | Class III | Terminated |
| D-689-2013 | 03-15-2013 | Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58 | Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing | Teva Pharmaceuticals USA, Inc. / 154,536 cartons | Class III | Terminated |
| D-690-2013 | 03-15-2013 | Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58 | Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing | Teva Pharmaceuticals USA, Inc. / 59,240 Cartons | Class III | Terminated |
| D-682-2013 | 03-15-2013 | Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58 Package NDCs: 0555-9025-42; 0555-9026-58; 0555-9027-42; 0555-9028-58 | Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing | Teva Pharmaceuticals USA, Inc. / 47,200 blister packs | Class III | Terminated |
| D-684-2013 | 03-15-2013 | Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58 Package NDCs: 0555-9034-79; 0555-9034-58 | Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing | Teva Pharmaceuticals USA, Inc. / 36,708 blister packs | Class III | Terminated |
| D-683-2013 | 03-15-2013 | Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66 Package NDCs: 0555-9123-66 | Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing | Teva Pharmaceuticals USA, Inc. / 54,412 blister packs | Class III | Terminated |
| D-497-2013 | 03-14-2013 | Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA Package NDCs: 0093-3134-91; 0093-3134-82; 0555-3134-82 | Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing | Teva Pharmaceuticals USA, Inc. / 120,049 blister packs | Class III | Terminated |
| D-811-2013 | 03-14-2013 | All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712 | Lack of Assurance of Sterility; potential for mold contamination | Med Prep Consulting, Inc. / N/A | Class II | Terminated |
| D-810-2013 | 03-14-2013 | Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712 | Non-Sterility; mold contamination | Med Prep Consulting, Inc. / 403883 bags | Class I | Terminated |
| D-496-2013 | 03-14-2013 | Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66 | Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing | Teva Pharmaceuticals USA, Inc. / 17,108 blister packs | Class III | Terminated |
| D-318-2013 | 03-12-2013 | Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01, | Failed Impurities/Degradation Specifications: 3 month stability testing. | L. Perrigo Co. / 21,667 bottles | Class III | Terminated |
| D-246-2013 | 03-12-2013 | Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66. Package NDCs: 0555-9123-66 | Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance. | Teva Pharmaceuticals USA, Inc. / 71,893 dispensers | Class III | Terminated |
| D-245-2013 | 03-12-2013 | Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per carton, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-9020-58. Package NDCs: 0555-9020-79; 0555-9020-58 | Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance. | Teva Pharmaceuticals USA, Inc. / 17,661 blister cards | Class III | Terminated |
| D-233-2013 | 03-11-2013 | Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 , | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products / 511 30 count bottles, 4103 100 count bottles | Class II | Terminated |
| D-232-2013 | 03-11-2013 | Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade, LLC Orlando, FL | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products / 250 bottles | Class II | Terminated |
| D-234-2013 | 03-11-2013 | Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. . | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products / 4103 bottles | Class II | Terminated |
| D-235-2013 | 03-11-2013 | BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC, BoostYourGrade, LLC, Orlando, FL 32826 | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products / 723 bottles | Class II | Terminated |
| D-302-2013 | 03-11-2013 | Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1. | Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station. | Hi-Tech Pharmacal Co., Inc. / 11,472 bottles | Class III | Terminated |
| D-828-2013 | 03-11-2013 | Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA | Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug. | Green Planet Inc / 429,619 capsules | Class I | Terminated |
| D-236-2013 | 03-11-2013 | Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products / 472 - 30 count bottles; 203 - 60 count bottles; 458 - 90 count bottles | Class II | Terminated |
| D-230-2013 | 03-11-2013 | Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90 count, d) 180 count , OTC, BoostYourGrade, LLC Orlando, FL 32826 | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products / 557 30 count botles, 672 60 count bottles, 1,102 90 count bottles, 250 180 count bottles | Class II | Terminated |
| D-231-2013 | 03-11-2013 | NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Manufactured & Packaged in the USA for NOOTROPA.COM. DEVELOPED BY: Digital Superfuture Limited Arntel Building 9B 148 Des Voeux Rd. Hong Kong. | Marketed Without an Approved NDA/ANDA: The products are unapproved drugs | Palmer Natural Products / 672 bottles | Class II | Terminated |
| D-244-2013 | 03-11-2013 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA | Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer | Gsms / 6158 bottles | Class II | Terminated |
| D-918-2013 | 03-11-2013 | Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA | Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 2190 syringes | Class II | Terminated |
| D-208-2013 | 03-07-2013 | Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health / 91,872/1-oz. tubes and 94,464/2-oz. tubes | Class III | Terminated |
| D-207-2013 | 03-07-2013 | Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054. | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health / 240,120/2-oz. tubes and 429,144/4-oz. tubes | Class III | Terminated |
| D-841-2013 | 03-07-2013 | Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30 | Subpotent drug: low fill volume in some of the capsules | Sanofi US / 2,462 bottles | Class II | Terminated |
| D-211-2013 | 03-07-2013 | 4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health / 227,124 bottles | Class III | Terminated |
| D-210-2013 | 03-07-2013 | 4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health / 44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles | Class III | Terminated |
| D-209-2013 | 03-07-2013 | 4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. Package NDCs: 0067-2086-01; 0067-2086-05; 0067-2086-15 | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. | Novartis Consumer Health / 538,092/.5-fl. oz. bottles, 1,186,740/1-oz. bottles, and 138,528/1.25-fl. oz bottles | Class III | Terminated |
| D-202-2013 | 03-05-2013 | Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01. Package NDCs: 68382-018-06; 68382-018-14; 68382-018-16; 68382-018-01; 68382-018-05; 68382-018-10; 68382-019-06; 68382-019-14; 68382-019-16; 68382-019-01; 68382-019-05; 68382-019-10; 68382-020-06; 68382-020-14; 68382-020-16; 68382-020-01; 68382-020-05; 68382-020-10; 68382-021-06; 68382-021-14; 68382-021-16; 68382-021-01; 68382-021-05; 68382-021-10; 68382-101-06; 68382-101-14; 68382-101-16; 68382-101-01; 68382-101-05; 68382-101-10 | Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle. | Zydus Pharmaceuticals USA Inc / 13,320 bottles | Class II | Terminated |
| D-226-2013 | 03-04-2013 | SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No 260681, CareFusion, Leawood, KS 66211. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 8,960,000 applicators | Class II | Terminated |
| D-229-2013 | 03-04-2013 | FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 544,500 kits | Class II | Terminated |
| D-227-2013 | 03-04-2013 | Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260307, NDC 54365-200-99, CareFusion, Leawood, KS 66211. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 929,000 kits | Class II | Terminated |
| D-224-2013 | 03-04-2013 | SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 698,000 applicators | Class II | Terminated |
| D-225-2013 | 03-04-2013 | SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net 0.67 mL each) per case, Cat. No 260431, NDC 54365-151-01, CareFusion, Leawood, KS 66211; and c) 3000-count applicators (Net 0.67 mL each) per case, Reorder TA6200, Manufactured for: Tri-State Hospital Supply Corporation, Howell, MI 48843. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 3,032,000 applicators | Class II | Terminated |
| D-228-2013 | 03-04-2013 | Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211. | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. | CareFusion 213, LLC / 46,500 kits | Class II | Terminated |
| D-596-2013 | 03-02-2013 | Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00 | Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible. | Physicians Total Care, Inc. / 76 Tubes | Class III | Terminated |
| D-398-2014 | 02-27-2013 | FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots | Mutual Pharmaceutical Company, Inc. / | Class III | Terminated |
| D-400-2014 | 02-27-2013 | Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots | Mutual Pharmaceutical Company, Inc. / | Class III | Terminated |
| D-623-2013 | 02-27-2013 | 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11 Package NDCs: 0338-0553-11; 0338-0553-18 | Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL. | Baxter Healthcare Corp. / 317,280 bags | Class II | Terminated |
| D-399-2014 | 02-27-2013 | Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07 | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots | Mutual Pharmaceutical Company, Inc. / | Class III | Terminated |
| D-269-2013 | 02-26-2013 | Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10 | Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets.. | Mylan Pharmaceuticals Inc. / 2,405 bottles | Class III | Terminated |
| D-247-2013 | 02-26-2013 | Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960. Package NDCs: 0093-4136-64; 0093-4136-73; 0093-4137-64; 0093-4137-73 | Defective Container: This recall is being carried out due to the potential for improperly sealed bottles. | Teva Pharmaceuticals USA, Inc. / 62,187 bottles | Class II | Terminated |
| D-886-2013 | 02-26-2013 | Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887 | Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment. | Sanofi-Synthelabo / 998 Bottles | Class II | Terminated |
| D-315-2013 | 02-26-2013 | QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02 Package NDCs: 0409-6629-12; 0409-6629-02; 0409-6970-10 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. / 139,200 vials | Class II | Terminated |
| D-313-2013 | 02-26-2013 | Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 Package NDCs: 0409-3213-11; 0409-3213-12 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. / 114,000 vials | Class II | Terminated |
| D-316-2013 | 02-26-2013 | Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73 Package NDCs: 0409-7299-83; 0409-7299-73 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. / 266,900 vials | Class II | Terminated |
| D-314-2013 | 02-26-2013 | Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04 Package NDCs: 0409-6102-19; 0409-6102-02; 0409-6102-18; 0409-6102-04; 0409-6102-20; 0409-6102-10 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. / 259,050 vials | Class II | Terminated |
| D-223-2013 | 02-25-2013 | Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA. Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25 | Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection. | Hospira Inc. / 68,020 vials | Class II | Terminated |
| D-346-2014 | 02-22-2013 | Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6. Package NDCs: 68180-280-01; 68180-281-01; 68180-281-02; 68180-281-11 | Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity. | Lupin Pharmaceuticals Inc. / 4896 bottles | Class III | Terminated |
| D-579-2013 | 02-22-2013 | Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN | cGMP Deviation | Petnet Solution Inc / 28 doses | Class II | Terminated |
| D-577-2013 | 02-19-2013 | Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ. | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. | Novartis Consumer Health / a) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes | Class III | Terminated |
| D-575-2013 | 02-19-2013 | Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428. | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. | Novartis Consumer Health / 219,600 tubes | Class III | Terminated |
| D-574-2013 | 02-19-2013 | Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN. | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.. | Novartis Consumer Health / 99,660 tubes | Class III | Terminated |
| D-576-2013 | 02-19-2013 | Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43 | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. | Novartis Consumer Health / 41,400 Boxes | Class III | Terminated |
| D-573-2013 | 02-19-2013 | Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33. | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. | Novartis Consumer Health / 818,064 (12-gm) tubes and 836,376 (30-gm) tubes | Class III | Terminated |
| D-243-2013 | 02-18-2013 | 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045 | Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal. | Hospira Inc. / 624,240 units | Class II | Terminated |
| D-216-2013 | 02-18-2013 | PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716 | Subpotent; 12 month time point for the active ingredient Phenylephrine HCl. | L. Perrigo Co. / 60,048 Blister packs | Class III | Terminated |
| D-304-2013 | 02-15-2013 | Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880. | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged. | Warner Chilcott Company LLC / 17,136 bottles | Class III | Terminated |
| D-305-2013 | 02-15-2013 | Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866 | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged. | Warner Chilcott Company LLC / 6,408 bottles | Class III | Terminated |
| D-303-2013 | 02-15-2013 | Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866 | Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged. | Warner Chilcott Company LLC / 27,509 bottles | Class III | Terminated |
| D-239-2013 | 02-15-2013 | Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807 | Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point. | Dr Reddys Laboratories Tennessee LLC / 4236 Bottles | Class II | Terminated |
| D-206-2013 | 02-15-2013 | METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24) | Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal. | Hospira Inc. / 567,624 bags | Class II | Terminated |
| D-205-2013 | 02-13-2013 | ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28 | Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) . | Watson Laboratories Inc / 136,720 cartons | Class II | Terminated |
