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FDA Recalls

Showing 1,831–1,840 of 18,043 recalls

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Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62 Class II

Reason: Failed Dissolution Specifications

Teva Pharmaceuticals USA, Inc 20240307 Terminated

Distributed: USA nationwide.

VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01 Class II

Reason: cGMP Diviations

Apothecus Pharmaceutical Corp. 20240321 Terminated

Distributed: USA nationwide.

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10 Class II

Reason: Failed dissolution specifications

Amneal Pharmaceuticals of New York, LLC 20231226 Terminated

Distributed: Product was distributed nationwide.

VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated

Distributed: Nationwide in the USA

SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated

Distributed: Nationwide in the USA

SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated

Distributed: Nationwide in the USA

Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated

Distributed: Nationwide in the USA

PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility) Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated

Distributed: Nationwide in the USA

PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612. Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated

Distributed: Nationwide in the USA

PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540. Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated

Distributed: Nationwide in the USA

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