🍔 Food 💊 Drugs 🏥 Medical Devices
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04 Class II

Reason: Defective container: lack of seal integrity.

Lupin Pharmaceuticals Inc. 20240508 Terminated
Distributed: USA Nationwide
View Details
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00 Class II

Reason: Presence of Foreign Substance: metal in tablet

Rubicon Research Private Limited 20240506 Ongoing
Distributed: Nationwide
View Details
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08 Class II

Reason: Lack of Assurance of Sterility

Imprimis NJOF, LLC 20240514 Ongoing
Distributed: Nationwide within the United States
View Details
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08 Class II

Reason: Lack of Assurance of Sterility

Imprimis NJOF, LLC 20240514 Ongoing
Distributed: Nationwide within the United States
View Details
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01 Class II

Reason: Lack of Assurance of Sterility

Imprimis NJOF, LLC 20240514 Ongoing
Distributed: Nationwide within the United States
View Details
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01 Class II

Reason: Lack of Assurance of Sterility

Imprimis NJOF, LLC 20240514 Ongoing
Distributed: Nationwide within the United States
View Details
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01 Class II

Reason: Lack of Assurance of Sterility

Imprimis NJOF, LLC 20240514 Ongoing
Distributed: Nationwide within the United States
View Details
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64 Class I

Reason: Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate

Revive Rx LLC dba Revive Rx Pharmacy 20240420 Ongoing
Distributed: USA Nationwide
View Details
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52 Class II

Reason: Lack of Assurance of Sterility: Leaking vials

Dr. Reddy's Laboratories, Inc. 20240523 Ongoing
Distributed: Nationwide within the United States
View Details
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64 Class II

Reason: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.

Genentech, Inc. 20240520 Terminated
Distributed: Nationwide within the United States
View Details
Page 175 of 1,805 | Showing 10 recalls
Data provided by openFDA