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-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: 16729-183-01; 16729-183-17; 16729-182-01; 16729-182-17; 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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; 59746-393-30; 59746-393-90; 59746-393-67; 59746-393-32 | 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; 59746-393-30; 59746-393-90; 59746-393-67; 59746-393-32 | 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; 59746-393-30; 59746-393-90; 59746-393-67; 59746-393-32 | 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-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 | 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-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-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-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-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-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-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 | 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-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-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-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-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-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-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-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-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-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; 55289-866-20; 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; 55289-866-14 | 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-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-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 |
| 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-0030-2019 | 08-03-2018 | CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Product #282472, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 529,536 cans | 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-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-0055-2019 | 08-03-2018 | OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Division of Valeant Pharmaceuticals, North America LLC, Bridgewater, NJ 08807. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 3,442,536 bottles | Class II | Terminated |
| D-0057-2019 | 08-03-2018 | Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co,. 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 63684 7. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 1008 bottles | Class II | Terminated |
| D-0029-2019 | 08-03-2018 | CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landover, MD 20785, 1-877-846-9949, UPC 3 41520 00175 8. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 4464 tubes | 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-0047-2019 | 08-03-2018 | Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-316-03, UPC 8 40986 01516 8. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 4992 bottles | Class II | Terminated |
| D-0061-2019 | 08-03-2018 | Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Extra Moisturizing, 12 Hour, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7004-01, UPC 3 11917 18534 7. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 286,176 bottles | 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-0046-2019 | 08-03-2018 | Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL) can, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 8 40986 02998 1. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 10,584 cans | 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-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-0078-2019 | 08-03-2018 | Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901) | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-0056-2019 | 08-03-2018 | Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%), Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave., Kansas City, KS 66106, UPC 0 70038 59328 7. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 2,112 bottles | Class II | Terminated |
| D-0049-2019 | 08-03-2018 | QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, UPC 6 35515 99202 3. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 4,200 tubes | Class II | Terminated |
| D-0053-2019 | 08-03-2018 | Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00660 4. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 22,392 bottles | Class II | Terminated |
| D-0065-2019 | 08-03-2018 | dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7. | Failed Stability Specifications: separation of product and failure for actives. | Product Quest Manufacturing LLC / 9,480 tubes | Class II | Terminated |
| D-0075-2019 | 08-03-2018 | Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-0034-2019 | 08-03-2018 | CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 285,840 tubes | Class II | Terminated |
| D-0044-2019 | 08-03-2018 | Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 2. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 8592 bottles | Class II | Terminated |
| D-0076-2019 | 08-03-2018 | Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201 | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-0052-2019 | 08-03-2018 | Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL OZ (89 mL) can, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00659 8. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 16,944 cans | Class II | Terminated |
| D-0035-2019 | 08-03-2018 | CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, Product #277790. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 552 bottles | Class II | Terminated |
| D-0037-2019 | 08-03-2018 | DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072, UPC 7 27510 00373 3 . | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 786,720 bottles | Class II | Terminated |
| D-0069-2019 | 08-03-2018 | Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0. | Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients. | Product Quest Manufacturing LLC / 6,516 tubes | Class III | Terminated |
| D-0050-2019 | 08-03-2018 | QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL) bottle UPC 6 35515 98845 3; b) 3 FL OZ (89 mL) bottle UPC 6 35515 95042 9, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 172,800 bottles | Class II | Terminated |
| D-0036-2019 | 08-03-2018 | Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a) 3 FL OZ (89 mL) bottle UPC 0 93351 01833 6; b) 1.5 FL OZ (45 mL) bottle UPC 0 93351 01834 3, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256 | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 21,492 bottles | Class II | Terminated |
| D-0080-2019 | 08-03-2018 | Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-0070-2019 | 08-03-2018 | Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7. | Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients. | Product Quest Manufacturing LLC / 7,944 tubes | Class III | Terminated |
| D-0043-2019 | 08-03-2018 | HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 . | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 3264 bottles | Class II | Terminated |
| D-0063-2019 | 08-03-2018 | Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,NDC 0363-7005-01, UPC 3 11917 18537 8. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 355,056 bottles | Class II | Terminated |
| D-0072-2019 | 08-03-2018 | Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3. | Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid. | Product Quest Manufacturing LLC / 1,440 tubes | Class II | Terminated |
| D-1076-2018 | 08-03-2018 | Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02 | Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label. | Huijing (Shanghai) Bio-tech Co., Ltd. / 75,000 pads | Class III | Terminated |
