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 July 04, 2025 and include a total of 16930 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0024-2019 | 08-28-2018 | Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-6580-43 Packaged by: Humco Texarkana, TX 75501 USA | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Humco Holding Group, Inc / 10 kilograms | Class II | Terminated |
| D-1184-2018 | 08-28-2018 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01 Package NDCs: 0409-1140-01 | Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point | Pfizer Inc. / 1,580 vials | Class III | Terminated |
| D-0022-2019 | 08-28-2018 | Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-8077-43 Packaged by: Humco Texarkana, TX 75501 | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Humco Holding Group, Inc / Unknown | Class II | Terminated |
| D-0023-2019 | 08-28-2018 | Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Humco Holding Group, Inc / Unknown. | Class II | Terminated |
| D-1189-2018 | 08-27-2018 | Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032. | Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide. | SCA Pharmaceuticals, Inc. / 1384 bags | Class I | Terminated |
| D-0003-2019 | 08-27-2018 | Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417. | Subpotent Drug: Product may not have the active ingredient present in the bag. | QuVa Pharma, Inc. / 528 bags | Class I | Terminated |
| D-0025-2019 | 08-27-2018 | Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53. Package NDCs: 0378-7281-85; 0378-7281-53 | Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs. | Mylan Pharmaceuticals Inc. / 5,790 cartons (526,890 tablets) | Class III | Terminated |
| D-1205-2018 | 08-27-2018 | MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03 Package NDCs: 59746-001-06; 59746-001-03; 59746-002-04; 59746-002-06; 59746-003-14; 59746-015-04 | Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay. | Jubilant Cadista Pharmaceuticals, Inc. / 89,722 blister pack | Class III | Terminated |
| D-0093-2019 | 08-24-2018 | Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00 | CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient. | RemedyRepack Inc. / 2 bottles of 90 tablets (180 tablets) | Class II | Terminated |
| D-1183-2018 | 08-24-2018 | Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01 | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity. | Akorn, Inc. / 23,788 100-count bottles | Class II | Terminated |
| D-0085-2019 | 08-24-2018 | Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011 | CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident. | Valeant Pharmaceuticals North America LLC / 119,594 tubes | Class II | Terminated |
| D-0086-2019 | 08-24-2018 | Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155 | CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident. | Valeant Pharmaceuticals North America LLC / 5,016 tubes | Class II | Terminated |
| D-0296-2019 | 08-24-2018 | Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1 | CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | LGM Pharma LLC / 1,307 kg | Class II | Terminated |
| D-0084-2019 | 08-24-2018 | Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028 | CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident. | Valeant Pharmaceuticals North America LLC / 18,408 bottles | Class II | Terminated |
| D-1076-2019 | 08-23-2018 | Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA | Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper | Pacific Compounding Pharmacy & Consultations Inc / 41.4 mL | Class II | Terminated |
| D-1201-2018 | 08-23-2018 | Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02 | Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia | Hellolife / 4,358 bottles | Class I | Terminated |
| D-1200-2018 | 08-23-2018 | Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02 | Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia | Hellolife / 989 bottles | Class I | Terminated |
| D-1202-2018 | 08-23-2018 | Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-025-02 | Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia | Hellolife / 370 bottles | Class I | Terminated |
| D-1169-2018 | 08-23-2018 | Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0 Package NDCs: 0573-0174-30; 0573-0171-30; 0573-0171-03; 0573-0171-32; 0573-0170-30; 0573-0170-01; 0573-0170-32; 0573-0290-30; 0573-0290-01; 0573-0207-30; 0573-0232-30 | Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters. | Pfizer Global Supply / 17,136 bottles | Class II | Terminated |
| D-1214-2018 | 08-23-2018 | Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01 Package NDCs: 43386-540-01; 43386-540-05; 43386-541-01; 43386-541-05; 43386-542-01; 43386-542-05; 43386-543-01; 43386-543-05; 43386-544-01; 43386-544-05 | Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing. | LUPIN SOMERSET / 4716 bottle | Class III | Terminated |
| D-1203-2018 | 08-23-2018 | Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02 | Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia | Hellolife / 1,869 bottles | Class I | Terminated |
| D-0013-2019 | 08-22-2018 | THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0 | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Syntec Pharma Corp / 2 drums | Class II | Terminated |
| D-0014-2019 | 08-22-2018 | THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-9.9mcg/grain) active pharmaceutical ingredient; 25 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0 | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Syntec Pharma Corp / 486 kg | Class II | Terminated |
| D-1166-2018 | 08-21-2018 | Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 40 vials | Class II | Terminated |
| D-1157-2018 | 08-21-2018 | Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 167 vials | Class II | Terminated |
| D-1158-2018 | 08-21-2018 | Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 91 vials | Class II | Terminated |
| D-0006-2019 | 08-21-2018 | Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11 | CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Sichuan Friendly Pharmaceutical Co.,Ltd. / 2662 kg | Class II | Completed |
| D-1206-2018 | 08-21-2018 | Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01. Package NDCs: 16729-182-01; 16729-182-17; 16729-183-01; 16729-183-17; 16729-184-01; 16729-184-17 | Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg. | Accord Healthcare, Inc. / 46,632 bottles | Class I | Terminated |
| D-1128-2018 | 08-21-2018 | 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | CGMP Deviations | Baxter Healthcare Corporation / 33600 bags | Class II | Terminated |
| D-1164-2018 | 08-21-2018 | Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 32 vials | Class II | Terminated |
| D-1163-2018 | 08-21-2018 | Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 43 vials | Class II | Terminated |
| D-1162-2018 | 08-21-2018 | Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 81 vials | Class II | Terminated |
| D-1161-2018 | 08-21-2018 | Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 90 vials | Class II | Terminated |
| D-1165-2018 | 08-21-2018 | Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 11 vials | Class II | Terminated |
| D-1129-2018 | 08-21-2018 | Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01. | Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517. | Mayne Pharma Inc / 6456 bottles | Class III | Terminated |
| D-1160-2018 | 08-21-2018 | Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 114 vials | Class II | Terminated |
| D-1159-2018 | 08-21-2018 | Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 183 vials | Class II | Terminated |
| D-1156-2018 | 08-21-2018 | CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 39 vials | Class II | Terminated |
| D-1167-2018 | 08-21-2018 | Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 74 vials | Class II | Terminated |
| D-1146-2018 | 08-20-2018 | Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0 | CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient. | RemedyRepack Inc. / 3 bottles of 90 tablets (270 tablets overall) | Class II | Terminated |
| D-1213-2018 | 08-20-2018 | Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30. Package NDCs: 31722-726-30; 31722-726-90; 31722-726-01; 31722-726-10; 31722-726-31; 31722-726-32 | Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets. | Hetero Labs Limited Unit V / 98,016 bottles | Class II | Terminated |
| D-1134-2018 | 08-17-2018 | Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / 24468 bottles | Class II | Ongoing |
| D-1143-2018 | 08-17-2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / 22704 bottles | Class II | Ongoing |
| D-1141-2018 | 08-17-2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / 169,200 bottles | Class II | Ongoing |
| D-1145-2018 | 08-17-2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / 37704 bottles | Class II | Ongoing |
| D-1137-2018 | 08-17-2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / 89616 bottles | Class II | Ongoing |
| D-1135-2018 | 08-17-2018 | Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / 14016 bottles | Class II | Ongoing |
| D-1142-2018 | 08-17-2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / 50,784 bottles | Class II | Ongoing |
| D-1138-2018 | 08-17-2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / 66864 bottles | Class II | Ongoing |
| D-1140-2018 | 08-17-2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / 78144 bottles | Class II | Ongoing |
| D-1139-2018 | 08-17-2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / 46272 bottles | Class II | Ongoing |
| D-1144-2018 | 08-17-2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / 34320 bottles | Class II | Ongoing |
| D-1136-2018 | 08-17-2018 | Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Torrent Pharma Inc. / ALL | Class II | Ongoing |
| D-0081-2019 | 08-15-2018 | Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30 Package NDCs: 31722-726-30; 31722-726-90; 31722-726-01; 31722-726-10; 31722-726-31; 31722-726-32 | Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg. | Hetero Labs Limited Unit V / 98016 bottles | Class I | Ongoing |
| D-1107-2018 | 08-15-2018 | Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Preferred Pharmaceuticals, Inc / 9 bottles consisting of 90 tables each bottle | Class II | Terminated |
| D-1112-2018 | 08-14-2018 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08 | Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 408 cartons | Class III | Terminated |
| D-1188-2018 | 08-14-2018 | Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709 Package NDCs: 66302-206-01; 66302-206-02; 66302-206-03; 66302-206-04 | Defective Delivery System: Water ingress through the lower water cup sensor of the device. | United Therapeutics Corp. / 2801 devices | Class III | Terminated |
| D-1106-2018 | 08-14-2018 | Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90 Package NDCs: 59746-360-30; 59746-360-90; 59746-360-05; 59746-360-03; 59746-361-30; 59746-361-90; 59746-361-05; 59746-361-03; 59746-362-30; 59746-362-90; 59746-362-05; 59746-362-03; 59746-363-30; 59746-363-90; 59746-363-67; 59746-363-32 | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. | Jubilant Cadista Pharmaceuticals, Inc. / 7,048 bottles | Class III | Terminated |
| D-1105-2018 | 08-14-2018 | Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90 Package NDCs: 59746-360-30; 59746-360-90; 59746-360-05; 59746-360-03; 59746-361-30; 59746-361-90; 59746-361-05; 59746-361-03; 59746-362-30; 59746-362-90; 59746-362-05; 59746-362-03; 59746-363-30; 59746-363-90; 59746-363-67; 59746-363-32 | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. | Jubilant Cadista Pharmaceuticals, Inc. / 18,947 bottles | Class III | Terminated |
| D-1103-2018 | 08-14-2018 | Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30 Package NDCs: 59746-360-30; 59746-360-90; 59746-360-05; 59746-360-03; 59746-361-30; 59746-361-90; 59746-361-05; 59746-361-03; 59746-362-30; 59746-362-90; 59746-362-05; 59746-362-03; 59746-363-30; 59746-363-90; 59746-363-67; 59746-363-32 | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. | Jubilant Cadista Pharmaceuticals, Inc. / 10,577 bottles | Class III | Terminated |
| D-1104-2018 | 08-14-2018 | Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90 Package NDCs: 59746-360-30; 59746-360-90; 59746-360-05; 59746-360-03; 59746-361-30; 59746-361-90; 59746-361-05; 59746-361-03; 59746-362-30; 59746-362-90; 59746-362-05; 59746-362-03; 59746-363-30; 59746-363-90; 59746-363-67; 59746-363-32 | Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. | Jubilant Cadista Pharmaceuticals, Inc. / 9,552 bottles | Class III | Terminated |
| D-1132-2018 | 08-14-2018 | Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | AVKARE Inc. / 818 cartons (40,900 tablets) | Class II | Terminated |
| D-1130-2018 | 08-14-2018 | Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | AVKARE Inc. / 6776 cartons (338,800 tablets) | Class II | Terminated |
| D-1131-2018 | 08-14-2018 | Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | AVKARE Inc. / 728 cartons (36,400 tablets) | Class II | Terminated |
| D-1133-2018 | 08-14-2018 | Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | AVKARE Inc. / 1496 cartons (44,880 tablets) | Class II | Terminated |
| D-1172-2018 | 08-14-2018 | Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51 | Supterpotent Drug | Mckesson Corporation / 1531 cartons | Class II | Terminated |
| D-0004-2019 | 08-13-2018 | Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remedies, LLC P.O. Box 704, Franklin Lakes, NJ 07417 www.LivingWellRemedies.com. Made in the USA | Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results. | Living Well Remedies, LLC / 128 (2 fl oz spray bottles) | Class I | Completed |
| D-1077-2018 | 08-13-2018 | Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03 Package NDCs: 68180-512-02; 68180-512-30; 68180-512-09; 68180-512-01; 68180-512-03; 68180-513-30; 68180-513-03; 68180-513-01; 68180-513-09; 68180-513-02; 68180-513-05; 68180-517-03; 68180-517-01; 68180-517-30; 68180-517-09; 68180-517-04; 68180-517-02; 68180-980-03; 68180-980-30; 68180-980-01; 68180-980-09; 68180-980-05; 68180-980-02; 68180-981-01; 68180-981-03; 68180-981-30; 68180-981-09; 68180-981-02; 68180-981-05; 68180-982-01; 68180-982-02; 68180-982-30; 68180-982-03; 68180-982-09; 68180-979-01; 68180-979-03; 68180-979-30; 68180-979-09; 68180-514-01; 68180-514-02; 68180-514-03; 68180-514-09; 68180-514-30; 68180-514-05; 68180-515-01; 68180-515-02; 68180-515-03; 68180-515-09; 68180-515-30; 68180-515-05; 68180-516-01; 68180-516-02; 68180-516-03; 68180-516-09; 68180-516-30 | Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet. | Lupin Pharmaceuticals Inc. / 11,706 bottles | Class II | Terminated |
| D-0091-2019 | 08-10-2018 | Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92 | Lack of Process Controls | Westlab Pharmacy, Inc. dba Westlab Pharmacy / 7 droptainers | Class II | Terminated |
| D-0089-2019 | 08-10-2018 | Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00 | Incorrect Product Formulation | Westlab Pharmacy, Inc. dba Westlab Pharmacy / 80 syringes | Class II | Terminated |
| D-1100-2018 | 08-10-2018 | Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | RemedyRepack Inc. / 9 bottles of 90 = 810 tablets | Class II | Terminated |
| D-1101-2018 | 08-10-2018 | Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | RemedyRepack Inc. / 21 bottles of 90 = 1890 tablets | Class II | Terminated |
| D-1102-2018 | 08-10-2018 | Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | RemedyRepack Inc. / 36 bottles of 90 = 3240 tablets | Class II | Terminated |
| D-0090-2019 | 08-10-2018 | ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05 | Lack of Process Controls | Westlab Pharmacy, Inc. dba Westlab Pharmacy / 222 syringes | Class II | Terminated |
| D-1099-2018 | 08-09-2018 | Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99. Package NDCs: 51267-890-99; 51267-890-07 | Defective Container: Customer complaints of punctures in the bottle. | Orexigen Therapeutics, Inc. / 95,296 bottles | Class III | Terminated |
| D-1116-2018 | 08-08-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902 Package NDCs: 31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227489 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Hetero Labs Limited Unit V / 441,408 bottles | Class II | Completed |
| D-1115-2018 | 08-08-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905 Package NDCs: 31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227479 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Hetero Labs Limited Unit V / 441,408 bottles | Class II | Completed |
| D-1113-2018 | 08-08-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307 Package NDCs: 31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227453 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Hetero Labs Limited Unit V / 316,380 bottles | Class II | Completed |
| D-1114-2018 | 08-08-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908 Package NDCs: 31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227469 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Hetero Labs Limited Unit V / 394,896 bottles | Class II | Completed |
| D-1168-2018 | 08-08-2018 | Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10 | Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide | Akorn, Inc. / 8,574 bottles | Class III | Terminated |
| D-1186-2018 | 08-07-2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01 | Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound. | Mylan Pharmaceuticals Inc. / 11,799 bottles of 100 | Class III | Terminated |
| D-1127-2018 | 08-07-2018 | Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bottles, NDC 55289-866-14; f) 20-count bottles, NDC 55289-866-20; g) 28-count bottles, NDC 55289-866-28; h) 30-count bottles, NDC 55289-866-30; i) 120-count bottles, NDC 55289-866-98; j) 300-count bottles, NDC 55289-866-87; k) 400-count bottles, NDC 55289-866-74; Rx only, Packaged By PD-Rx Pharmaceuticals, Oklahoma City, OK 73127. Package NDCs: 55289-866-02; 55289-866-04; 55289-866-06; 55289-866-07; 55289-866-10; 55289-866-14; 55289-866-20; 55289-866-28; 55289-866-30; 55289-866-50; 55289-866-60; 55289-866-71; 55289-866-74; 55289-866-85; 55289-866-86; 55289-866-87; 55289-866-90; 55289-866-93; 55289-866-98; 55289-866-01; 55289-866-82; 55289-866-95 | Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results. | PD-Rx Pharmaceuticals, Inc. / 6,641 bottles | Class II | Terminated |
| D-1187-2018 | 08-07-2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05 | Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound. | Mylan Pharmaceuticals Inc. / 656 500-count bottles | Class III | Terminated |
| D-0099-2019 | 08-06-2018 | Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / 3,397 bottles | Class II | Terminated |
| D-0096-2019 | 08-06-2018 | Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / 27,816 bottles | Class II | Terminated |
| D-0101-2019 | 08-06-2018 | Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / N/A | Class II | Terminated |
| D-0100-2019 | 08-06-2018 | Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / 82,291 bottles | Class II | Terminated |
| D-0102-2019 | 08-06-2018 | PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / N/A | Class II | Terminated |
| D-0097-2019 | 08-06-2018 | Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / 3,785 bottles | Class II | Terminated |
| D-0098-2019 | 08-06-2018 | Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / 13,225 bottles | Class II | Terminated |
| D-0071-2019 | 08-03-2018 | CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7. | Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus. | Product Quest Manufacturing LLC / 25,596 sticks | Class II | Terminated |
| D-0041-2019 | 08-03-2018 | meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (88 mL) UPC 7 08820 74430 1, Dist. By Meijer Distribution, Inc., Grand Rapids, MI 49544 . | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 182,568 bottles | Class II | Terminated |
| D-0077-2019 | 08-03-2018 | Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-0062-2019 | 08-03-2018 | Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 361,104 bottles | Class II | Terminated |
| D-0073-2019 | 08-03-2018 | CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29525 0. | Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient. | Product Quest Manufacturing LLC / 11,016 cans | Class II | Terminated |
| D-0033-2019 | 08-03-2018 | CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 29380 5 Product #459367. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 42,792 bottles | Class II | Terminated |
| D-0039-2019 | 08-03-2018 | Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 . | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 5040 tubes | Class II | Terminated |
| D-0028-2019 | 08-03-2018 | Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottle, Distributed by: Scherer Labs International, LLC., 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02747 52531 1. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 4040 bottles | Class II | Terminated |
| D-0064-2019 | 08-03-2018 | Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 533,016 bottles | Class II | Terminated |
| D-0038-2019 | 08-03-2018 | FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 46,056 cans | Class II | Terminated |
