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-1281-2020 | 05-26-2020 | Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97. | Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product. | Jubilant Cadista Pharmaceuticals, Inc. / 1,313,333 tablets | Class III | Terminated |
| D-1291-2020 | 05-26-2020 | Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01 Package NDCs: 29300-468-05; 29300-468-10; 29300-468-50; 29300-468-01; 29300-136-01; 29300-136-05; 29300-136-10; 29300-136-50; 29300-137-01; 29300-137-05; 29300-137-10; 29300-137-25; 29300-135-01; 29300-135-05; 29300-135-10; 29300-135-50 | Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container. | UNICHEM PHARMACEUTICALS USA INC / 190,992 bottles | Class III | Terminated |
| D-1314-2020 | 05-26-2020 | Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30 | Failed Impurities/ Degradation Specifications | Aurobindo Pharma USA Inc. / 13322 bottles | Class III | Terminated |
| D-1315-2020 | 05-26-2020 | Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30 | Failed Impurities/ Degradation Specifications | Aurobindo Pharma USA Inc. / 7547 bottles | Class III | Terminated |
| D-1285-2020 | 05-22-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02 Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Some bottles may contain mixed strengths of the product. | Teva Pharmaceuticals USA / 33,280 bottles | Class II | Terminated |
| D-1287-2020 | 05-22-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0973-02 Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Some bottles may contain mixed strengths of the product. | Teva Pharmaceuticals USA / 84,209 bottles | Class II | Terminated |
| D-1288-2020 | 05-22-2020 | Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. Package NDCs: 0904-0430-95; 0904-0430-04; 0904-0430-06 | Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result. | The Harvard Drug Group / 16,443 cartons | Class II | Terminated |
| D-1300-2020 | 05-22-2020 | NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-331-01. Package NDCs: 42192-327-01; 42192-327-30; 42192-327-90; 42192-329-01; 42192-329-30; 42192-329-10; 42192-329-90; 42192-330-01; 42192-330-30; 42192-330-10; 42192-330-90; 42192-331-01; 42192-331-30; 42192-331-10; 42192-331-90; 42192-328-01; 42192-328-30; 42192-328-90 | Superpotent Drug. | Acella Pharmaceuticals, LLC / 49,128 bottles | Class I | Terminated |
| D-1286-2020 | 05-22-2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0777-02 Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Some bottles may contain mixed strengths of the product. | Teva Pharmaceuticals USA / 41,348 bottles | Class II | Terminated |
| D-1299-2020 | 05-22-2020 | NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-330-01. Package NDCs: 42192-327-01; 42192-327-30; 42192-327-90; 42192-329-01; 42192-329-30; 42192-329-10; 42192-329-90; 42192-330-01; 42192-330-30; 42192-330-10; 42192-330-90; 42192-331-01; 42192-331-30; 42192-331-10; 42192-331-90; 42192-328-01; 42192-328-30; 42192-328-90 | Superpotent Drug. | Acella Pharmaceuticals, LLC / 29,304 bottles | Class I | Terminated |
| D-1298-2020 | 05-22-2020 | NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01. Package NDCs: 42192-327-01; 42192-327-30; 42192-327-90; 42192-329-01; 42192-329-30; 42192-329-10; 42192-329-90; 42192-330-01; 42192-330-30; 42192-330-10; 42192-330-90; 42192-331-01; 42192-331-30; 42192-331-10; 42192-331-90; 42192-328-01; 42192-328-30; 42192-328-90 | Superpotent Drug. | Acella Pharmaceuticals, LLC / 112,140 bottles | Class I | Terminated |
| D-1293-2020 | 05-19-2020 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11 Package NDCs: 62584-693-11; 62584-693-21 | Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life). | American Health Packaging / 15,755 cartons | Class II | Terminated |
| D-1277-2020 | 05-19-2020 | LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL. | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date. | Wuhan Bingbing Pharmaceutical Co., Ltd. / 4,960 boxes | Class II | Ongoing |
| D-1376-2020 | 05-19-2020 | Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01 | Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded | Flexion Therapeutics, Inc. / 792 kits | Class III | Terminated |
| D-1279-2020 | 05-19-2020 | Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1. | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date. | Wuhan Bingbing Pharmaceutical Co., Ltd. / 1,800 pouches | Class II | Ongoing |
| D-1280-2020 | 05-19-2020 | Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05. | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date. | Wuhan Bingbing Pharmaceutical Co., Ltd. / 72,600 boxes | Class II | Ongoing |
| D-1278-2020 | 05-19-2020 | LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1. | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date. | Wuhan Bingbing Pharmaceutical Co., Ltd. / 54,000 boxes | Class II | Ongoing |
| D-1284-2020 | 05-15-2020 | Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02 | Failed impurities/ degradation specifications: Out of specification for organic impurities. | TRIOVA PHARMACEUTICALS LLC / 210 grams | Class II | Terminated |
| D-1276-2020 | 05-15-2020 | Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98), i) 210-count (NDC 55289-866-71), j) 300-count (NDC 55289-866-87), k) 400-count (NDC 55289-866-74), Rx only, PD-Rx Pharmaceuticals Incorporated 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 | PD-Rx Pharmaceuticals, Inc. / 14,030 bottles | Class II | Terminated |
| D-1310-2020 | 05-15-2020 | EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, UPC: 859623000030; 859623000177; 859623000573; Display UPC: 859623000092; 859623000108; 859623000139; 859623000146; 859623000184; 859623000535; 859623001037. | Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations. | Eco Lips Inc / 68,400 tubes | Class II | Terminated |
| D-1272-2020 | 05-14-2020 | Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05. Package NDCs: 76282-405-30; 76282-405-90; 76282-405-01; 76282-405-05; 76282-406-30; 76282-406-90; 76282-406-01; 76282-406-05 | Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing. | InvaGen Pharmaceuticals, Inc. / 2,202 bottles | Class III | Terminated |
| D-1282-2020 | 05-13-2020 | Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25. | Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants. | West-Ward Columbus Inc / 3336 Bottles | Class III | Terminated |
| D-1274-2020 | 05-13-2020 | Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. Package NDCs: 0143-2112-50; 0143-2112-05; 0143-2112-20 | Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result. | West-Ward Columbus Inc / 68,376 bottles | Class II | Terminated |
| D-1328-2020 | 05-11-2020 | Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin | BIOTA Biosciences LLC / N/A | Class II | Terminated |
| D-1326-2020 | 05-11-2020 | Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin | BIOTA Biosciences LLC / N/A | Class II | Terminated |
| D-1329-2020 | 05-11-2020 | Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin | BIOTA Biosciences LLC / N/A | Class II | Terminated |
| D-1330-2020 | 05-11-2020 | Sterile Curcumin 50mg/mL, 10 mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin | BIOTA Biosciences LLC / N/A | Class II | Terminated |
| D-1327-2020 | 05-11-2020 | Sterile Curcumin, 4mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin | BIOTA Biosciences LLC / N/A | Class II | Terminated |
| D-1317-2020 | 05-11-2020 | Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05 Package NDCs: 13668-268-30; 13668-268-01; 13668-268-10; 13668-268-31; 13668-268-05; 13668-271-01; 13668-271-10; 13668-271-49; 13668-271-05 | Failed Dissolution Specifications | Torrent Pharma Inc. / 6228 Bottles | Class II | Terminated |
| D-1270-2020 | 05-08-2020 | LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09 | Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide. | ICU Medical Inc / 93,648 flexible container | Class I | Terminated |
| D-1271-2020 | 05-05-2020 | Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50 Package NDCs: 67457-187-50 | Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution. | Mylan Institutional LLC / 3,010 vials | Class II | Terminated |
| D-1585-2020 | 05-05-2020 | Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4 | Short Fill | Exela Pharma Sciences LLC / 23,775 vials | Class III | Terminated |
| D-1262-2020 | 04-24-2020 | Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61 Package NDCs: 0904-6734-61; 0904-6736-61; 0904-6737-61; 0904-6735-61 | Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing. | The Harvard Drug Group / 678 cartons | Class III | Terminated |
| D-1256-2020 | 04-24-2020 | Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10 Package NDCs: 43598-509-30; 43598-509-90; 43598-509-10; 43598-510-30; 43598-510-90; 43598-510-10 | Discoloration: product contains brown pellets | Dr. Reddy's Laboratories, Inc. / 1752 bottles | Class III | Terminated |
| D-1335-2020 | 04-23-2020 | R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350 | Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac | QuVa Pharma, Inc. / 17,050 syringes | Class III | Terminated |
| D-1259-2020 | 04-21-2020 | Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0 Package NDCs: 54643-5646-1; 54643-5648-1; 54643-5651-1; 54643-5647-0; 54643-5653-0; 54643-5655-0 | Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins | Sandoz, Inc / 17,500 units | Class II | Terminated |
| D-1297-2020 | 04-20-2020 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-161-00; 63323-161-01; 63323-162-11; 63323-162-51; 63323-162-00; 63323-162-01; 63323-162-03; 63323-162-02 | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC / 3,497,575 vials | Class II | Terminated |
| D-1266-2020 | 04-20-2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08 Package NDCs: 0573-0871-08; 0573-0871-11 | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card | Glaxosmithkline Consumer Healthcare Holdings / 288 packages | Class III | Terminated |
| D-1268-2020 | 04-20-2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08 Package NDCs: 0573-0873-08; 0573-0873-11 | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card | Glaxosmithkline Consumer Healthcare Holdings / 360 packages | Class III | Terminated |
| D-1267-2020 | 04-20-2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08 Package NDCs: 0573-0872-08; 0573-0872-11 | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card | Glaxosmithkline Consumer Healthcare Holdings / 288 packages | Class III | Terminated |
| D-1296-2020 | 04-20-2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-161-00; 63323-161-01; 63323-162-11; 63323-162-51; 63323-162-00; 63323-162-01; 63323-162-03; 63323-162-02 | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC / 5,314,400 vials | Class I | Terminated |
| D-1250-2020 | 04-20-2020 | Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03 | Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles. | Lupin Pharmaceuticals Inc. / 11,808 bottles | Class II | Terminated |
| D-1257-2020 | 04-18-2020 | Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11 | Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers. | B. Braun Medical Inc / 22,488 Duplex containers | Class I | Terminated |
| D-1253-2020 | 04-15-2020 | Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15 Package NDCs: 60846-301-15 | CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. | Amneal Pharmaceuticals of New York, LLC / 11258 bottles | Class II | Terminated |
| D-1252-2020 | 04-15-2020 | Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01 Package NDCs: 68180-405-01; 68180-407-03; 68180-407-04; 68180-416-08; 68180-416-11; 68180-423-11; 68180-423-08 | Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. | Lupin Pharmaceuticals Inc. / 4,518 bottles | Class II | Terminated |
| D-1246-2020 | 04-15-2020 | Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433 | cGMP Deviations | H J Harkins Company Inc dba Pharma Pac / 9,000 tablets | Class II | Terminated |
| D-1489-2020 | 04-15-2020 | KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.810.KORE. | Chemical Contamination; product contains elevated levels of lead | Summitt Labs / 236 bottles | Class I | Terminated |
| D-1244-2020 | 04-14-2020 | Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100 | cGMP deviations: Presence of foreign material (Teflon)introduced at the production level. | B & B Pharmaceuticals, Inc. / 3,825 grams | Class II | Terminated |
| D-1269-2020 | 04-14-2020 | Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419. | Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil. | MasterPharm LLC / 7260 capsules | Class I | Terminated |
| D-1177-2020 | 04-06-2020 | Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1219-2020 | 04-06-2020 | Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1218-2020 | 04-06-2020 | Bi-Est (8:2)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1216-2020 | 04-06-2020 | Bi-Est (50/50/Progesterone 0.2 mg/70 mg Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1210-2020 | 04-06-2020 | Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream 100 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1182-2020 | 04-06-2020 | Estradiol Vag Cream 0.01% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 7 tubes | Class II | Terminated |
| D-1180-2020 | 04-06-2020 | Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1217-2020 | 04-06-2020 | Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1185-2020 | 04-06-2020 | Estradiol 1.8 mg capsule 30 cap bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1181-2020 | 04-06-2020 | Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1178-2020 | 04-06-2020 | Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 2 tubes | Class II | Terminated |
| D-1192-2020 | 04-06-2020 | Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1195-2020 | 04-06-2020 | Ergotamine Tartrate 1 mg/Caffeine 100 mg Base Suppository (Pink) 48 count box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 box | Class II | Terminated |
| D-1189-2020 | 04-06-2020 | Bi-Est (1:1) Progesterone/Testost 1.0 mg/60 mg/0.5 mg/mL Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1183-2020 | 04-06-2020 | Testosterone w/ Atrevis 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1224-2020 | 04-06-2020 | Testosterone w/Cosmetic HRT Base 20 mg (2%) Cream 30 GM jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1212-2020 | 04-06-2020 | Bi-Est (1:1)/Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1215-2020 | 04-06-2020 | Bi-Est (8:2)/Progesterone 2/100 mg/mL capsule 90 caps bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1213-2020 | 04-06-2020 | Bi-Est (50/50)/Progesterone/Testosterone 1.5 mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1196-2020 | 04-06-2020 | Diethylstilbestrol 1 mg capsule 300 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1228-2020 | 04-06-2020 | Levothyroxin (T4)/Liothyronine (T3) SR 130 mg/175 mg capsule 21 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1187-2020 | 04-06-2020 | Bi-Est (8:2) Progest/Test 2/80/3 mg/mL cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1176-2020 | 04-06-2020 | Testosterone W/Cosmetic HRT Base 100 MG (10%) Cream 30 GM, tubes Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 4 tubes | Class II | Terminated |
| D-1209-2020 | 04-06-2020 | Estriol 5 mg Suppository 36 each box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 box | Class II | Terminated |
| D-1175-2020 | 04-06-2020 | Estriol Vaginal Cream (0.1%) 1 mg Cream 30 GM tubes, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 8 tubes | Class II | Terminated |
| D-1190-2020 | 04-06-2020 | Progesterone/Versa Base 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1198-2020 | 04-06-2020 | Bi-Est 8:2/Progesterone/Testosterone DHEA 4.0/100/1/25.0 mg capsules 90 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1226-2020 | 04-06-2020 | Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 suppositories, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 2 boxes | Class II | Terminated |
| D-1199-2020 | 04-06-2020 | Bi-Est 1:1/Progesterone/Testosterone 2.0/100/0.25 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 2 tubes | Class II | Terminated |
| D-1201-2020 | 04-06-2020 | Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1221-2020 | 04-06-2020 | Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1214-2020 | 04-06-2020 | Bi-Est (50/50)/Progesterone/Testost 1.5/100/0.5 mg Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1191-2020 | 04-06-2020 | Progesterone 200 mg Capsules 90 capsules, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 3 bottles | Class II | Terminated |
| D-1206-2020 | 04-06-2020 | Hydromorphone Oral 1 mg/mL Solution 240 mL, bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1202-2020 | 04-06-2020 | Bi-Est (8:2)/Progest/Test/DHEA 6/50/0.5/10 mg/mL Cream 30 mL, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1200-2020 | 04-06-2020 | Bi-Est 1:1/Progest/DHEA 1/40/5 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1227-2020 | 04-06-2020 | Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 2 bottles | Class II | Terminated |
| D-1220-2020 | 04-06-2020 | Paregoric Alternate Elixir 300 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1222-2020 | 04-06-2020 | Testosterone in Atrevis 75 mg/mL Gel 90 GMS tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1194-2020 | 04-06-2020 | Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1205-2020 | 04-06-2020 | Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1193-2020 | 04-06-2020 | Bi-Est (8:2)/DHEA/Testosterone 0.8 mg/ 9/0.4 mg/0.2 mg/mL Cream 6 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1204-2020 | 04-06-2020 | Testosterone in Atrevis 50 mg/mL Gel 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1188-2020 | 04-06-2020 | Bi-Est (1:1) Progest/Test 0.5 mg/1.5 mg/mL cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1197-2020 | 04-06-2020 | Bi-Est 8:2/Progesterone 2.5 mg/150/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1208-2020 | 04-06-2020 | Naltrexone 4.5 mg/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 bottle | Class II | Terminated |
| D-1184-2020 | 04-06-2020 | Testosterone w/ Atrevis 100 mg/mL GEL, 90 gm pump, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 3 bottles | Class II | Terminated |
| D-1225-2020 | 04-06-2020 | Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
| D-1203-2020 | 04-06-2020 | Bi-Est (50/50)/Progesterone 1.25 mg/80 mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 2 tubes | Class II | Terminated |
| D-1186-2020 | 04-06-2020 | Bi-Est (1:1) Progest/Test 0.5 mg/40 mg/10.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 tube | Class II | Terminated |
| D-1223-2020 | 04-06-2020 | Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL | Lack of Processing Control | The Medicine Shoppe Pharmacy / 1 jar | Class II | Terminated |
