Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0102-05
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0122-30
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0121-30
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0074-30
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0101-30
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIDiluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0113-10
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0024-10
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIRE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIRE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIQM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0020-10
Lack of assurance of sterility.
- 2022-06-01FDA-DrugGlaxoSmithKline LLCClass IIITivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
- 2022-06-01FDA-DrugDirect RxClass IILosartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- 2022-06-01FDA-DrugDirect RxClass IILosartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- 2022-06-01FDA-DrugDirect RxClass IILosartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- 2022-06-01FDA-DrugPreferred Pharmaceuticals, Inc.Class IILosartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-06-01FDA-DrugPreferred Pharmaceuticals, Inc.Class IILosartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-06-01FDA-DrugEco Lips, IncClass IIIHigher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxate (7.5%), Oxybenzone (3%); Distributed by: Higher Education Skincare, 1.833.251.0388
Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
- 2022-06-01FDA-DrugNoven Pharmaceuticals IncClass IIDaytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3
Defective Delivery System: customer complaints exceeded respective action limits.
- 2022-06-01FDA-DrugDirect RxClass IIZonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
- 2022-06-01FDA-DrugRemedyRepack Inc.Class IILosartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- 2022-06-01FDA-DrugRemedyRepack Inc.Class IILosartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- 2022-06-01FDA-DrugRemedyRepack Inc.Class IILosartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-05-25FDA-DrugCardinal Health Inc.Class IITrulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
- 2022-05-25FDA-DrugCardinal Health Inc.Class IITrulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
- 2022-05-25FDA-DrugCardinal Health Inc.Class IHumalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
- 2022-05-25FDA-DrugApotex Corp.Class IIISirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
- 2022-05-25FDA-DrugAmerican Health PackagingClass IIINitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
- 2022-05-25FDA-DrugBestco LLCClass IIIOpen Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5
Subpotent drug: Low OOS for menthol content at the three month room temperature.
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