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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0447-2021 | 03-15-2021 | DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 318 droptainers | Class II | Terminated |
| D-0540-2021 | 03-15-2021 | HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 236 bottles | Class II | Terminated |
| D-0563-2021 | 03-15-2021 | medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 148 syringes | Class II | Terminated |
| D-0467-2021 | 03-15-2021 | Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1 bottle | Class II | Terminated |
| D-0548-2021 | 03-15-2021 | Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1371 bottles | Class II | Terminated |
| D-0445-2021 | 03-15-2021 | MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 64 droptainers | Class II | Terminated |
| D-0539-2021 | 03-15-2021 | ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 55 Boxes | Class II | Terminated |
| D-0532-2021 | 03-15-2021 | Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 205 bottles | Class II | Terminated |
| D-0475-2021 | 03-15-2021 | Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 41 bottles | Class II | Terminated |
| D-0552-2021 | 03-15-2021 | LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 49 bottles | Class II | Terminated |
| D-0560-2021 | 03-15-2021 | Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distributed by: AMAG Pharmaceuticals, Inc. Waltam, MA 02451, NDC 64011-601-28 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 205 cartons | Class II | Terminated |
| D-0452-2021 | 03-15-2021 | CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 17 patches | Class II | Terminated |
| D-0547-2021 | 03-15-2021 | LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2854 bottles | Class II | Terminated |
| D-0401-2021 | 03-15-2021 | NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 4 bottles | Class II | Terminated |
| D-0414-2021 | 03-15-2021 | Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 72 tubes | Class II | Terminated |
| D-0466-2021 | 03-15-2021 | Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland Package NDCs: 70515-625-01; 70515-610-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 13 packets | Class II | Terminated |
| D-0441-2021 | 03-15-2021 | ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 29 bottles | Class II | Terminated |
| D-0587-2021 | 03-15-2021 | Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 31 cartons | Class II | Terminated |
| D-0408-2021 | 03-15-2021 | OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 339 bottles | Class II | Terminated |
| D-0525-2021 | 03-15-2021 | ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 122 inhalers | Class II | Terminated |
| D-0411-2021 | 03-15-2021 | COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60045 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 12 bottles | Class II | Terminated |
| D-0422-2021 | 03-15-2021 | BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILM | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 249 CARTONS | Class II | Terminated |
| D-0506-2021 | 03-15-2021 | Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA Package NDCs: 62175-617-46; 62175-617-43; 62175-180-46; 62175-180-43; 62175-618-46; 62175-618-43 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 4 bottles | Class II | Terminated |
| D-0533-2021 | 03-15-2021 | TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 28 tubes | Class II | Terminated |
| D-0577-2021 | 03-15-2021 | EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5986-27 Package NDCs: 0093-5986-19; 0093-5986-27; 0093-5985-19; 0093-5985-27 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 414 boxes | Class II | Terminated |
| D-0586-2021 | 03-15-2021 | TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 86 BOTTLE | Class II | Terminated |
| D-0488-2021 | 03-15-2021 | FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement 100 Tablets Distributed by: H2-Pharma, LLC 2010 Berry Chase Place Montgomery, AL 36117 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 54 bottles | Class II | Terminated |
| D-0494-2021 | 03-15-2021 | Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 West-Ward Pharmaceutical Corp Eatontown, NJ 07724 USA Package NDCs: 0143-9722-01; 0143-9722-24; 0143-9721-01; 0143-9721-24; 0143-9720-01; 0143-9720-24 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 35 bags | Class II | Terminated |
| D-0439-2021 | 03-15-2021 | AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 373 bottles | Class II | Terminated |
| D-0420-2021 | 03-15-2021 | Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 759 bottles | Class II | Terminated |
| D-0565-2021 | 03-15-2021 | HYDROCORTISONE 1% 30gm cream | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 143 tubes | Class II | Terminated |
| D-0502-2021 | 03-15-2021 | PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 237 bottles | Class II | Terminated |
| D-0567-2021 | 03-15-2021 | Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30 Package NDCs: 50484-010-30; 50484-010-90 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1391 tubes | Class II | Terminated |
| D-0432-2021 | 03-15-2021 | GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 3 CARTON | Class II | Terminated |
| D-0418-2021 | 03-15-2021 | Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC. Package NDCs: 0456-1207-30; 0456-1214-11; 0456-1214-30; 0456-1214-63; 0456-1214-90; 0456-1221-30; 0456-1228-30; 0456-1228-90; 0456-1228-63; 0456-1228-11; 0456-1229-29; 0456-1229-04 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 659 bottles | Class II | Terminated |
| D-0555-2021 | 03-15-2021 | Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56 Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-28; 0069-0471-03; 0069-0471-28 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 848 bottles | Class II | Terminated |
| D-0448-2021 | 03-15-2021 | Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612. Package NDCs: 59385-021-01; 59385-021-60; 59385-022-01; 59385-022-60; 59385-023-01; 59385-023-60; 59385-024-01; 59385-024-60; 59385-025-01; 59385-025-60; 59385-026-01; 59385-026-60; 59385-027-01; 59385-027-60 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 96 cartons | Class II | Terminated |
| D-0595-2021 | 03-15-2021 | CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIAL Package NDCs: 69680-112-01; 69680-112-25; 69680-112-10; 69680-113-10; 69680-113-99; 69680-121-05; 69680-121-30; 69680-121-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 6 boxes | Class II | Terminated |
| D-0318-2021 | 03-11-2021 | ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4. | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc / 1569 devices | Class II | Terminated |
| D-0317-2021 | 03-11-2021 | ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 18031 5. | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc / 301 devices | Class II | Terminated |
| D-0305-2021 | 03-11-2021 | Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01. Package NDCs: 25021-315-01; 25021-315-99; 25021-315-98 | Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product. | Sagent Pharmaceuticals Inc / 3716 cartons | Class II | Terminated |
| D-0308-2021 | 03-11-2021 | Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10 | Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing. | Breckenridge Pharmaceutical, Inc / 3,146 bottles | Class II | Terminated |
| D-0365-2021 | 03-10-2021 | heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL) bottle, Heal The World, LLC, Draper, UT 84020, UPC 6 19988 44038 0. | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. | PNHC, LLC. / 139,806 bottles | Class I | Terminated |
| D-0790-2021 | 03-10-2021 | aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; b) 7.0 oz (198.5g) tube, UPC 6 87806 30007 9, NDC 76305-302-02; c) 16 oz (453.6g)Bottle w/ Pump, UPC 6 87806 30016 1, NDC 76305-302-03; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005, Package NDCs: 76305-302-03; 76305-302-02; 76305-302-01 | CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products. | China Gel Inc / 3458 tubes | Class II | Ongoing |
| D-0788-2021 | 03-10-2021 | CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g) jar, UPC 6 87806 10004 2, NDC 76305-300-02; c) 6 OZ (170 g) tube, UPC 6 87806 10006 2, NDC 76305-300-03; d) 8 OZ (226.8g) jar, UPC 6 87806 10008 2, NDC 76305-300-04; e) 16 OZ (453.6g), Bottle w/ Pump, UPC 6 87806 10016 7, NDC 76305-300-03; f) 128 OZ (3.78L) Gallon, UPC 6 87806 10128 7, NDC 76305-300-06; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005, Package NDCs: 76305-300-02; 76305-300-03; 76305-300-04; 76305-300-05; 76305-300-06; 76305-300-07; 76305-300-13 | CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products. | China Gel Inc / 92,472 each | Class II | Ongoing |
| D-0789-2021 | 03-10-2021 | CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC 6 87806 20004 1, NDC 76305-301-02 ; c) 6 OZ (170 g) tube, UPC 6 87806 20006 5, NDC 76305-301-03; d) 8 oz (226.8 g) Jar, UPC 6 87806 20008 9, NDC 76305-301-04; e) 16 oz ( 453.6 g) Bottle w/ Pump, UPC 6 87806 20016 4, NDC 76305-301-05; f) 120 oz (3.78L) gallon, UPC 6 87806 20128 4, NDC 76305-301-06: Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005, Package NDCs: 76305-301-02; 76305-301-03; 76305-301-04; 76305-301-05; 76305-301-06; 76305-301-07; 76305-301-13 | CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products. | China Gel Inc / 40,289 each | Class II | Ongoing |
| D-0659-2021 | 03-10-2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243. | CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated. | Sanit Technologies, LLC dba Durisan / 43,164 canisters TOTAL | Class II | Terminated |
| D-0657-2021 | 03-10-2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243, UPC 8 52379 00631 8. | Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold. | Sanit Technologies, LLC dba Durisan / 42,905 canisters TOTAL | Class I | Terminated |
| D-0656-2021 | 03-10-2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content 10 oz bottle, (UPC 8 52379 00697 4); g) 550 mL Net Content 18.59 oz bottle, (UPC 8 52379 00620 2) ; h) 1000 mL Net Content 33.81 oz kidney bottle dispensing 0.4 or 0.8 each actuation, (UPC 8 50008 48507 7 and 8 52379 00610 3); and i) 1 Gallon Net Content 128 oz bottle, (UPC 8 52379 00621 9); Sanit Technologies, LLC 7810 25th Court East, Unit 106 Sarasota, Florida 34243 | Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold. | Sanit Technologies, LLC dba Durisan / 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL | Class I | Terminated |
| D-0658-2021 | 03-10-2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content 10 oz bottle, (UPC 8 52379 00697 4); g) 550 mL Net Content 18.59 oz bottle, (UPC 8 52379 00620 2) ; h) 1000 mL Net Content 33.81 oz kidney bottle dispensing 0.4 or 0.8 each actuation, (UPC 8 50008 48507 7 and 8 52379 00610 3); and i) 1 Gallon Net Content 128 oz bottle, (UPC 8 52379 00621 9); Sanit Technologies, LLC 7810 25th Court East, Unit 106 Sarasota, Florida 34243 | CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated. | Sanit Technologies, LLC dba Durisan / 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL | Class II | Terminated |
| D-0313-2021 | 03-09-2021 | 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09 Package NDCs: 0990-7138-09; 0990-7138-36; 0990-6138-22; 0990-6138-03; 0990-7972-05; 0990-7972-07 | Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use | ICU Medical Inc / 425,628 bottles | Class II | Terminated |
| D-0314-2021 | 03-09-2021 | Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01. Package NDCs: 57894-650-01; 57894-650-02; 57894-640-01; 57894-640-04; 57894-640-11; 57894-640-99; 57894-640-03; 57894-640-06; 57894-651-01; 57894-651-02; 57894-651-04; 57894-651-11; 57894-651-22; 57894-651-99; 57894-651-92 | Temperature Abuse | Cardinal Health Inc. / 48 boxes | Class III | Terminated |
| D-0301-2021 | 03-08-2021 | Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07 | Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing | Akorn, Inc. / 8,183 unit dose cups | Class II | Terminated |
| D-0309-2021 | 03-04-2021 | Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01 | Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing. | Teva Pharmaceuticals USA / 1,416 vials | Class III | Terminated |
| D-0358-2021 | 03-02-2021 | Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152; Packaged Exclusively By: A-S Medication Solutions LLC, Libertyville, IL 60048, Product # 6967-0; NDC: 50090-5350-0; contained within Health Essentials Kit, Kit Contains: 1 bottle hand sanitzer, 1 reusable face mask, 1 bottle Acetaminophen 500 mg, 1 bag cough drops, 1 digital thermometer, 50 disposable gloves. Package NDCs: 50090-5350-0; 50090-5350-1 | Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label. | A-S Medication Solutions LLC. / 201,600 kits | Class I | Terminated |
| D-0299-2021 | 03-02-2021 | Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-2; b) Professional Sample Kit: 3 single dose vials of Menotropins for injection, 3 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-3; Rx Only, Manufactured for Ferring Pharmaceuticals Inc. Parsippany. NJ 07054. Diluent manufactured for Ferring Pharmaceuticals Inc. Package NDCs: 55566-7501-1; 55566-7501-2; 55566-7502-0; 55566-1600-0; 55566-7501-3 | Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP | Ferring Pharmaceuticals Inc / 1,155,601 cartons/5 vials per carton 12546 physician samples | Class III | Terminated |
| D-0300-2021 | 03-02-2021 | Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330 | cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site. | Direct Rx / 17 bottles | Class II | Terminated |
| D-0649-2021 | 02-26-2021 | Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03 Package NDCs: 47781-355-11; 47781-355-03; 47781-356-11; 47781-356-03; 47781-357-11; 47781-357-03; 47781-358-11; 47781-358-03 | Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) | Alvogen, Inc / 9,696 cartons | Class II | Terminated |
| D-0292-2021 | 02-26-2021 | Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01. Package NDCs: 43598-349-01; 43598-350-01 | Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing. | Dr. Reddy's Laboratories, Inc. / 16,449 bottles | Class II | Terminated |
| D-0289-2021 | 02-22-2021 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96 Package NDCs: 47335-506-96; 47335-507-97 | Subpotent | SUN PHARMACEUTICAL INDUSTRIES INC / 37,400 cartons/60 vials per carton | Class III | Terminated |
| D-0296-2021 | 02-19-2021 | Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5555-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel. | Noven Pharmaceuticals Inc / 934,140 patches | Class II | Terminated |
| D-0298-2021 | 02-19-2021 | Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03 | Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card. | Jubilant Cadista Pharmaceuticals, Inc. / 635,400 cartons | Class III | Terminated |
| D-0295-2021 | 02-19-2021 | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5554-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel. | Noven Pharmaceuticals Inc / 786,900 patches | Class II | Terminated |
| D-0293-2021 | 02-19-2021 | Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel. | Noven Pharmaceuticals Inc / 473,280 patches | Class II | Terminated |
| D-0294-2021 | 02-19-2021 | Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5553-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel. | Noven Pharmaceuticals Inc / 551,670 patches | Class II | Terminated |
| D-0291-2021 | 02-19-2021 | Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities | Dr. Reddy's Laboratories, Inc. / 10,440 90-count and 224,710 500-count bottles | Class III | Terminated |
| D-0316-2021 | 02-18-2021 | Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. Package NDCs: 68382-048-01; 68382-048-10; 68382-049-01; 68382-049-10 | Crystallization: customer complaints for crystallization in finished product. | Zydus Pharmaceuticals (USA) Inc / 1,638 packs | Class I | Terminated |
| D-0315-2021 | 02-18-2021 | Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. Package NDCs: 68382-048-01; 68382-048-10; 68382-049-01; 68382-049-10 | Crystallization: customer complaints for crystallization in finished product. | Zydus Pharmaceuticals (USA) Inc / 816 packs | Class I | Terminated |
| D-0287-2021 | 02-17-2021 | Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 unit-dose) tablets per carton (NDC 43598-344-31); Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540; Made in India. Package NDCs: 43598-344-30; 43598-344-90; 43598-344-10; 43598-344-31; 43598-345-30; 43598-345-90; 43598-345-05; 43598-345-31 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / a) 1350 bottles; b) 147 cartons | Class II | Terminated |
| D-0288-2021 | 02-17-2021 | Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA NDC 76318-334-50 Package NDCs: 76318-334-50 | Lack of Assurance of Sterility | The General Hospital Corporation / 50 mL vial | Class II | Terminated |
| D-0306-2021 | 02-17-2021 | Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05 | Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions | Edge Pharma, LLC / 213 kits | Class III | Terminated |
| D-0310-2021 | 02-15-2021 | Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. | Adams.Secret.co / 218 boxes | Class I | Terminated |
| D-0311-2021 | 02-15-2021 | Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6. | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. | Adams.Secret.co / N/A | Class I | Terminated |
| D-0297-2021 | 02-15-2021 | Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray) Package NDCs: 0703-4502-01; 0703-4502-04 | Chemical contamination; Unknown brown residue adhering to the inside of one vial. | Teva Pharmaceuticals USA / 9,452 cartons | Class II | Terminated |
| D-0277-2021 | 02-10-2021 | Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618. Package NDCs: 0703-4502-01; 0703-4502-04 | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 29,357 vials | Class II | Terminated |
| D-0276-2021 | 02-10-2021 | Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 248,565 vials | Class II | Terminated |
| D-0285-2021 | 02-10-2021 | Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 705,745 vials | Class II | Terminated |
| D-0282-2021 | 02-10-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0045-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / N/A | Class II | Terminated |
| D-0279-2021 | 02-10-2021 | Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 33,6697 vials | Class II | Terminated |
| D-0281-2021 | 02-10-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 5,378 vials | Class II | Terminated |
| D-0275-2021 | 02-10-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 5,086 vials | Class II | Terminated |
| D-0273-2021 | 02-10-2021 | Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 26,373 vials | Class II | Terminated |
| D-0271-2021 | 02-10-2021 | Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 50 vials | Class II | Terminated |
| D-0283-2021 | 02-10-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0043-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 6,710 vials | Class II | Terminated |
| D-0272-2021 | 02-10-2021 | Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 2,577 vials | Class II | Terminated |
| D-0280-2021 | 02-10-2021 | Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1995-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 12,609 vials | Class II | Terminated |
| D-0284-2021 | 02-10-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0063-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 15,043 vials | Class II | Terminated |
| D-0278-2021 | 02-10-2021 | Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-5657-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 4,806 vials | Class II | Terminated |
| D-0274-2021 | 02-10-2021 | Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1985-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 12,629 vials | Class II | Terminated |
| D-0251-2021 | 02-05-2021 | Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40 Package NDCs: 62756-129-40; 62756-129-44; 62756-129-45 | Failed Impurity/Degradation Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 20,475 vials | Class III | Terminated |
| D-0259-2021 | 02-04-2021 | Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-133-01 | Failed Dissolution Specifications | Wilshire Pharmaceuticals Inc / 35928 bottles | Class II | Terminated |
| D-0258-2021 | 02-04-2021 | Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01 | Failed Dissolution Specifications | Wilshire Pharmaceuticals Inc / 2112 bottles | Class II | Terminated |
| D-0340-2021 | 02-02-2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15 | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Teligent Pharma, Inc. / N/A | Class III | Terminated |
| D-0338-2021 | 02-02-2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15 | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Teligent Pharma, Inc. / 104,784 tubes | Class III | Terminated |
| D-0261-2021 | 02-02-2021 | Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label) | Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) | Apotex Corp. / 6670 cartons | Class I | Ongoing |
| D-0339-2021 | 02-02-2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51 | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Teligent Pharma, Inc. / 79,416 tubes | Class III | Terminated |
| D-0262-2021 | 02-02-2021 | Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0796-4 UPC 360505079543 (carton) NDC 60505-0796-0 UPC (01)10360505079602 (label) | Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength) | Apotex Corp. / 6832 cartons | Class I | Ongoing |
| D-0319-2021 | 02-01-2021 | Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1 | Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer | Kimberly-Clark Corporation / 2,982 cases | Class II | Terminated |
| D-0260-2021 | 01-29-2021 | Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01. | Failed Dissolution Specifications | Akebia Therapeutics dba Keryx Biopharmaceutials, Inc / 17,664 bottles | Class III | Terminated |
| D-0250-2021 | 01-28-2021 | Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30) Package NDCs: 16729-471-08; 16729-472-08; 16729-473-03; 16729-474-03; 16729-474-05; 16729-472-30 | Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials | Accord Healthcare, Inc. / 502 cartons | Class III | Terminated |
