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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-859-2013 | 03-25-2013 | Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-860-2013 | 03-25-2013 | Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-858-2013 | 03-25-2013 | Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 408 vials | Class II | Terminated |
| D-880-2013 | 03-25-2013 | Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 12 vials | Class II | Terminated |
| D-867-2013 | 03-25-2013 | DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 3 vials | Class II | Terminated |
| D-872-2013 | 03-25-2013 | MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 18 vials | Class II | Terminated |
| D-876-2013 | 03-25-2013 | Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-869-2013 | 03-25-2013 | HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 261 vials | Class II | Terminated |
| D-878-2013 | 03-25-2013 | Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 597 vials | Class II | Terminated |
| D-881-2013 | 03-25-2013 | Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-871-2013 | 03-25-2013 | Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 3 vials | Class II | Terminated |
| D-879-2013 | 03-25-2013 | Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 862 vials | Class II | Terminated |
| D-862-2013 | 03-25-2013 | Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 71 vials | Class II | Terminated |
| D-857-2013 | 03-25-2013 | Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 1 vial | Class II | Terminated |
| D-863-2013 | 03-25-2013 | Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 23 vials | Class II | Terminated |
| D-248-2013 | 03-22-2013 | buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30. | Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point. | Actavis South Atlantic LLC / 555,672 bottles | Class III | Terminated |
| D-1060-2014 | 03-22-2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles) Package NDCs: 0591-0397-60; 0591-0397-19; 0591-0398-60 | Failed Tablet/Capsule Specifications: Broken tablets | Actavis Inc / 6,540 bottles | Class II | Terminated |
| D-817-2013 | 03-22-2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 Package NDCs: 0591-0397-60; 0591-0397-19; 0591-0398-60 | Failed Tablet/Capsule Specifications: Broken tablets | Watson Laboratories, Inc.-(Actavis) - Florida / 392,400 tablets | Class II | Terminated |
| D-250-2013 | 03-21-2013 | Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080. | Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose. | Precision Dose Inc. / 9,268 cases | Class II | Terminated |
| D-654-2013 | 03-20-2013 | Methylcobalamin 1250 mcg/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 / 36ml | Class II | Terminated |
| D-673-2013 | 03-20-2013 | Test cyp 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 / 12ml | Class II | Terminated |
| D-643-2013 | 03-20-2013 | HCG 1000 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-666-2013 | 03-20-2013 | Test Cyp 200 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 / unknown | Class II | Terminated |
| D-680-2013 | 03-20-2013 | Vancomycin 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 / 20ml total | Class II | Terminated |
| D-653-2013 | 03-20-2013 | Methionine/Choline/Inositol/ B-12, 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 / 255ml total | Class II | Terminated |
| D-660-2013 | 03-20-2013 | Pap 300 mg-phent 10 mg-prost 100 mcg, 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 / 96ml total | Class II | Terminated |
| D-636-2013 | 03-20-2013 | Cyclosporine 1% ophthalmic 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 / 55 ml | Class II | Terminated |
| D-639-2013 | 03-20-2013 | Estradiol Cypionate 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 / 95 ml total | Class II | Terminated |
| D-671-2013 | 03-20-2013 | Test Cyp 25 mg-e(2) blend 12 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 / 8ml | Class II | Terminated |
| D-656-2013 | 03-20-2013 | Mitomycin 0.04% 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 / 50ml total | Class II | Terminated |
| D-648-2013 | 03-20-2013 | Itraconazole 1% eye ointment, 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-667-2013 | 03-20-2013 | Test cyp 25 mg-Estadiol valerate 15 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-645-2013 | 03-20-2013 | HCG 500 units/ml, 10 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-651-2013 | 03-20-2013 | Medroxyprogesterone 150 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 / 220ml total | Class II | Terminated |
| D-676-2013 | 03-20-2013 | Test Cyp 50 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 / 3ml | Class II | Terminated |
| D-650-2013 | 03-20-2013 | Latanoprost 0.025% eye drop, 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 / 70ml total | Class II | Terminated |
| D-647-2013 | 03-20-2013 | Injection vehicle, 120 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 / N/A | Class II | Terminated |
| 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-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-646-2013 | 03-20-2013 | Hydroxyprogesterone 250 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 / N/A | Class II | Terminated |
| D-634-2013 | 03-20-2013 | Acetylcysteine 2 % 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 / 10ml | Class II | Terminated |
| D-679-2013 | 03-20-2013 | Tetracaine(buffered) 0.25% 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 / 474ml total | Class II | Terminated |
| D-641-2013 | 03-20-2013 | Estradiol Valerate 30 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 / 18ml total | 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-638-2013 | 03-20-2013 | Diazepam 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 / 222 ml 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 | 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-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-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 | 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. | 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-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-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-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 |
