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-1121-2015 | 05-15-2015 | Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT. | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 20/4 mL vials | Class II | Terminated |
| D-1123-2015 | 05-15-2015 | Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 20/1 mL vials | Class II | Terminated |
| D-1119-2015 | 05-15-2015 | Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 259/0.05 mL Syringes | Class II | Terminated |
| D-1124-2015 | 05-15-2015 | Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 1/1 mL. vial | Class II | Terminated |
| D-1125-2015 | 05-15-2015 | Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT. | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 32/2 mL vials | Class II | Terminated |
| D-1118-2015 | 05-15-2015 | Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 1/5 mL vial | Class II | Terminated |
| D-1127-2015 | 05-15-2015 | Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 2/5 mL vials | Class II | Terminated |
| D-1128-2015 | 05-15-2015 | Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 1/5 mL vial | Class II | Terminated |
| D-1120-2015 | 05-15-2015 | Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT. | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 1/5mL vial | Class II | Terminated |
| D-1139-2015 | 05-13-2015 | Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25. Package NDCs: 0641-6024-01; 0641-6024-10; 0641-6027-01; 0641-6027-25; 0641-6025-01; 0641-6025-10; 0641-6028-01; 0641-6028-10; 0641-6028-25; 0641-6026-01; 0641-6026-05; 0641-6029-01; 0641-6029-25; 0641-6030-01; 0641-6247-01; 0641-6247-25; 0641-6248-01; 0641-6248-10; 0641-6249-01; 0641-6249-10 | Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). | West-Ward Pharmaceutical Corp. / 14,649 Cartons | Class III | Terminated |
| D-1134-2015 | 05-12-2015 | Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon Stores, Inc. 650 Liberty Ave. Union, NJ 07083, UPC: 3 62211 93292 2. c) Health A2Z Maximum Strength HEARTBURN RELIEF, 8 Tablet Cartons, Manufactured for: A&Z Pharmaceutical Inc. Hauppauge, NY 11788. UPC: 3 62211 34929 4. d) MARKET BASKET Maximum Strength HEARTBURN RELIEF ACID CONTROL, 30 Tablet Cartons, Distributed by: Demoulas Supermarkets, Inc. 875 East St. Tewksbury, MA 01876, UPC: 0 49705 83147 2. | CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints. | Allegiant Health / 86,106 Cartons | Class II | Terminated |
| D-1112-2015 | 05-11-2015 | Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01 | Failed Dissolution Specifications: OOS result during stability testing | Teva Pharmaceuticals USA / 889 bottles | Class II | Terminated |
| D-1087-2015 | 05-07-2015 | QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12 | Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing. | Teva Pharmaceuticals USA / 233,364 Inhalers | Class III | Terminated |
| D-1145-2015 | 05-06-2015 | Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90 Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent drug | Dr. Reddy's Laboratories, Inc. / | Class III | Terminated |
| D-1144-2015 | 05-06-2015 | Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent drug | Dr. Reddy's Laboratories, Inc. / | Class III | Terminated |
| D-1146-2015 | 05-06-2015 | Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent drug | Dr. Reddy's Laboratories, Inc. / | Class III | Terminated |
| D-1143-2015 | 05-06-2015 | Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent drug | Dr. Reddy's Laboratories, Inc. / | Class III | Terminated |
| D-1142-2015 | 05-04-2015 | Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand) | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 2592 Blister Packs | Class III | Terminated |
| D-1064-2015 | 04-30-2015 | Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23 | Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. | Mission Pharmacal Co / 2,412 Kits | Class II | Terminated |
| D-1065-2015 | 04-30-2015 | Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23 | Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. | Mission Pharmacal Co / 1,992 Kits | Class II | Terminated |
| D-1063-2015 | 04-29-2015 | Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15. | Subpotent Drug | Janssen Pharmaceuticals, Inc. / 16,861 cartons/6 blister units (28 tablets) each | Class II | Terminated |
| D-0561-2016 | 04-29-2015 | Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07. | cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints. | PD-Rx Pharmaceuticals, Inc. / 17,533 bottles | Class II | Terminated |
| D-0560-2016 | 04-29-2015 | Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04. | cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints. | PD-Rx Pharmaceuticals, Inc. / 45,022 bottles | Class II | Terminated |
| D-1089-2015 | 04-28-2015 | Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11 | Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. | Teva Pharmaceuticals USA / 6195 vials | Class I | Terminated |
| D-1133-2015 | 04-28-2015 | PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029. | Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose. | SCA Pharmaceuticals / 50 bags | Class II | Terminated |
| D-1114-2015 | 04-28-2015 | KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20. Package NDCs: 63323-712-10; 63323-712-15; 63323-712-20; 63323-712-25 | Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids | Fresenius Kabi USA, LLC / 5,488 Bags | Class II | Terminated |
| D-1078-2015 | 04-24-2015 | Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25. | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Cipla Limited / 140,625 Vials | Class III | Terminated |
| D-0983-2015 | 04-24-2015 | Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607 | Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity | Romark Laboratories, L.C. / 32,893 bottles | Class II | Terminated |
| D-1337-2015 | 04-23-2015 | Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / ALL LOTS | Class II | Terminated |
| D-1342-2015 | 04-23-2015 | Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 335 vials (114 prescriptions) | Class II | Terminated |
| D-1412-2015 | 04-23-2015 | Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 211 presciptions | Class II | Terminated |
| D-1329-2015 | 04-23-2015 | Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017. | Presence of Particulate Matter | Mylan Institutional LLC / 8,340 vials | Class I | Terminated |
| D-1414-2015 | 04-23-2015 | Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 36 prescriptions | Class II | Terminated |
| D-1339-2015 | 04-23-2015 | Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 40 capsules ( 1 prescription) | Class II | Terminated |
| D-1410-2015 | 04-23-2015 | Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 5 prescriptions | Class II | Terminated |
| D-1411-2015 | 04-23-2015 | Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 61 prescriptions | Class II | Terminated |
| D-1407-2015 | 04-23-2015 | Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 2,380 capsules ( 39 prescriptions) | Class II | Terminated |
| D-1338-2015 | 04-23-2015 | Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 2,355 capsules ( 26 presciptions) | Class II | Terminated |
| D-1415-2015 | 04-23-2015 | Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 24 suppositories (24 prescriptions) | Class II | Terminated |
| D-1340-2015 | 04-23-2015 | Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 172 vials ( 100 prescriptions) | Class II | Terminated |
| D-1408-2015 | 04-23-2015 | Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 2,370 capsules (40 prescriptions) | Class II | Terminated |
| D-0974-2015 | 04-23-2015 | KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01 | Crystallization | RemedyRepack Inc. / 25 | Class II | Terminated |
| D-1216-2015 | 04-23-2015 | Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02. Package NDCs: 0409-1159-18; 0409-1159-01; 0409-1159-19; 0409-1159-02; 0409-1160-18; 0409-1160-01; 0409-1162-18; 0409-1162-01; 0409-1162-19; 0409-1162-02; 0409-1163-18; 0409-1163-01; 0409-1165-18; 0409-1165-01; 0409-1165-19; 0409-1165-02; 0409-9043-11; 0409-9043-01; 0409-9046-11; 0409-9046-01; 0409-9045-11; 0409-9045-01; 0409-9045-16; 0409-9045-17; 0409-9042-11; 0409-9042-01; 0409-9042-16; 0409-9042-17 | Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. | Hospira Inc. / 150,950 Vials | Class I | Terminated |
| D-1413-2015 | 04-23-2015 | Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 24 prescriptions | Class II | Terminated |
| D-1341-2015 | 04-23-2015 | Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 337 vials (112 prescriptions) | Class II | Terminated |
| D-1409-2015 | 04-23-2015 | Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | South Coast Specialty Compounding, Inc. / 540 capsules (11 prescriptions) | Class II | Terminated |
| D-1267-2015 | 04-22-2015 | Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 1,002 Drums | Class II | Terminated |
| D-1258-2015 | 04-22-2015 | Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 133,920 Bottles, B) 6705 Bottles, and C) 137,659 Bottles. | Class II | Terminated |
| D-1274-2015 | 04-22-2015 | Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0945-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 68,066 Bottles | Class II | Terminated |
| D-1255-2015 | 04-22-2015 | Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 146,959 Bottles, B) 73,445 Bottles. | Class II | Terminated |
| D-1243-2015 | 04-22-2015 | Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 124,034 Bottles | Class II | Terminated |
| D-1244-2015 | 04-22-2015 | Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 149,924 Bottles and B) 35,012 Bottles | Class II | Terminated |
| D-1262-2015 | 04-22-2015 | Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 36,213 Bottles and B) 12,824 Bottles. | Class II | Terminated |
| D-1256-2015 | 04-22-2015 | Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 152,164 Bottles and B) 50,991 Bottles. | Class II | Terminated |
| D-1253-2015 | 04-22-2015 | Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 407,958 Bottles | Class II | Terminated |
| D-1247-2015 | 04-22-2015 | Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 37,791 Bottles | Class II | Terminated |
| D-1251-2015 | 04-22-2015 | Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 848 Pouches | Class II | Terminated |
| D-1272-2015 | 04-22-2015 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0734-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 132,409 Bottles, B) 41,257 Bottles, C) 576 Pouches, and D) 6,429 Cartons. | Class II | Terminated |
| D-1254-2015 | 04-22-2015 | Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 491,360 Bottles | Class II | Terminated |
| D-1263-2015 | 04-22-2015 | Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 112,120 Bottles and B) 178,580 Cartons. | Class II | Terminated |
| D-1264-2015 | 04-22-2015 | Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 7,584 Bottles | Class II | Terminated |
| D-1260-2015 | 04-22-2015 | Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 63,203 Bottles and B) 6,094 Bottles. | Class II | Terminated |
| D-1257-2015 | 04-22-2015 | Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 128,594 Bottles, B) 25,472 Bottles, and C) 62,124 Bottles. | Class II | Terminated |
| D-1246-2015 | 04-22-2015 | Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 53,894 Bottles | Class II | Terminated |
| D-1252-2015 | 04-22-2015 | Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA . | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 33,422 Bottles and B) 940 Bottles. | Class II | Terminated |
| D-1268-2015 | 04-22-2015 | Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 16,276 Bottles | Class II | Terminated |
| D-1276-2015 | 04-22-2015 | Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 216,329 Bottles and B) 18,514 Bottles. | Class II | Terminated |
| D-1271-2015 | 04-22-2015 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0735-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 136,839 Bottles, B) 37,184 Bottles, C) 309 Pouches, and D) 9,764 Cartons. | Class II | Terminated |
| D-1248-2015 | 04-22-2015 | Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 280,520 Bottles, B) 571 Pouches, and C) 1,629,253 Cartons. | Class II | Terminated |
| D-1273-2015 | 04-22-2015 | Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 84,542 Bottles | Class II | Terminated |
| D-1269-2015 | 04-22-2015 | Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles. | Class II | Terminated |
| D-1277-2015 | 04-22-2015 | Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0905-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 68,969 Bottles | Class II | Terminated |
| D-1250-2015 | 04-22-2015 | Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 70,428 Bottles, B) 128,420 Bottles, and C) 8,101 Bottles. | Class II | Terminated |
| D-1249-2015 | 04-22-2015 | Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 59,729 Bottles | Class II | Terminated |
| D-1275-2015 | 04-22-2015 | Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 162,743 Bottles and B) 14,205 Bottles | Class II | Terminated |
| D-1261-2015 | 04-22-2015 | Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 174,571 Bottles, B) 66,960 Bottles, and C) 48,988 Bottles. | Class II | Terminated |
| D-1245-2015 | 04-22-2015 | Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 5,910 Bottles | Class II | Terminated |
| D-1270-2015 | 04-22-2015 | Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC, 20 Waterview Blvd. Parsippany, NJ 07054 USA . | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 77,967 Bottles, B) 26,785 Bottles, and C) 5,463 Cartons. | Class II | Terminated |
| D-1266-2015 | 04-22-2015 | Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / 539 Drums | Class II | Terminated |
| D-1259-2015 | 04-22-2015 | Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 121,608 Bottles, B) 11,000 Bottles, and C) 152,773 Bottles. | Class II | Terminated |
| D-1265-2015 | 04-22-2015 | Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. | CGMP Deviations: Firm did not adequately investigate customer complaints. | Wockhardt Usa Inc. / A) 69,008 Bottles, B) 399,730 Bottles, and C) 58,116 Bottles. | Class II | Terminated |
| D-1082-2015 | 04-21-2015 | NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01 Package NDCs: 47781-303-01 | Failed Dissolution Specification; 6 month time point | Alvogen, Inc / 13,392 bottles (100 count) | Class II | Terminated |
| D-1429-2015 | 04-20-2015 | IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) per carton, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. | Subpotent Drug: Low out-of-specification potency result of the drug product. | Akorn, Inc. / 370 kits | Class III | Terminated |
| D-1034-2016 | 04-18-2015 | Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10. Package NDCs: 0187-4100-10 | Failed Impurities/Degradation Specifications | Valeant Pharmaceuticals North America LLC / 6,321 bottles | Class III | Terminated |
| D-1035-2016 | 04-18-2015 | Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 68682-409-10. | Failed Impurities/Degradation Specifications | Valeant Pharmaceuticals North America LLC / 564,454 bottles | Class III | Terminated |
| D-1116-2015 | 04-17-2015 | Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01. | Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point. | Valeant Pharmaceuticals North America LLC / 93,237 Bottles | Class II | Terminated |
| D-967-2015 | 04-16-2015 | Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL) | Products failed the Antimicrobial Effectiveness Test | Tarmac Products, Inc. / 104,810 bottles | Class II | Terminated |
| D-968-2015 | 04-16-2015 | Well at Walgreens Regular Strength Antacid Liquid, Mint Flavor 12 FL OZ (355 mL) bottle | Products failed the Antimicrobial Effectiveness Test. | Tarmac Products, Inc. / 16,248 bottles | Class II | Terminated |
| D-966-2015 | 04-16-2015 | Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle, | Products failed the Antimicrobial Effectiveness Test | Tarmac Products, Inc. / 41,743 bottles | Class II | Terminated |
| D-1368-2015 | 04-15-2015 | Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 561,390 Bottles | Class I | Terminated |
| D-1115-2015 | 04-15-2015 | Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06 | Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point. | Sandoz, Inc / 1,023,430 units | Class III | Terminated |
| D-1367-2015 | 04-15-2015 | Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 200,688 Bottles | Class I | Terminated |
| D-1365-2015 | 04-15-2015 | Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 379,284 Bottles | Class I | Terminated |
| D-1364-2015 | 04-15-2015 | Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, Phenylephrine HCl Nasal Decongestant, 6 fl oz. (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-500-66, UPC 63824-50066-09 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 717,336 Bottles | Class I | Terminated |
| D-1369-2015 | 04-15-2015 | Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-01966-9, UPC 63824-52622-5 Package NDCs: 72854-165-26; 63824-503-66; 63824-019-66 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 416,220 Bottles | Class II | Terminated |
| D-1363-2015 | 04-15-2015 | Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1 Package NDCs: 63824-015-66; 63824-015-69 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 495036 Bottles | Class I | Terminated |
| D-1366-2015 | 04-15-2015 | Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360 mL), For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-526-22 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. | Reckitt Benckiser LLC / 561,390 Bottles | Class I | Terminated |
| D-0486-2015 | 04-14-2015 | Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144. Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 in, NDC: 52544-044-80, C) Haelan Tape (Fludroxycortide), Bulk Rolls, NDC: 55515-014-00. | Subpotent Drug: Flurandrenolide is subpotent. | Actavis Laboratories / 78,522 Cartons | Class III | Terminated |
| D-1356-2015 | 04-13-2015 | EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6618, NDC# 61553-618-61. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 48 bags | Class I | Terminated |
| D-1358-2015 | 04-13-2015 | EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6119, NDC# 61553-119-61. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 264 bags | Class I | Terminated |
