Read & Learn

FDA Recalls

Showing 3,071–3,080 of 18,043 recalls

Last checked for updates 2 days ago: No new recalls

Add Recipe

🍔 Food 💊 Drugs 🏥 Medical Devices

Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count bottle, NDC 16729-278-01, UPC 3 16729 27801 10 Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India Class II

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. 20230207 Terminated

Distributed: United States including Puerto Rico and Canada

Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01 Class II

Reason: CGMP Deviations: Potential product carryover.

Nephron Sc Inc 20230223 Terminated

Distributed: United States

Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16. Class III

Reason: Subpotent Drug

SCA Pharmaceuticals 20230224 Terminated

Distributed: Nationwide in the US.

Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25. Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20230222 Terminated

Distributed: Nationwide in the USA

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10. Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20230222 Terminated

Distributed: Nationwide in the USA

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10. Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20230222 Terminated

Distributed: Nationwide in the USA

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10. Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20230222 Terminated

Distributed: Nationwide in the USA

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25. Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20230222 Terminated

Distributed: Nationwide in the USA

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25. Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20230222 Terminated

Distributed: Nationwide in the USA

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25. Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20230222 Terminated

Distributed: Nationwide in the USA

1
...
306
307
308
309
310
...
1805

Page 308 of 1,805 | Showing 10 recalls

Data provided by openFDA