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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 5341–5360 of 17,755 recalls

Class IITerminated

Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-528-34

CIPLA

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

December 17, 2020 · DrugView details →

Class IITerminated

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02

Fresenius Kabi USA, LLC

Presence of Particulate Matter - found in reserve sample vials at the firm.

December 17, 2020 · DrugView details →

Class IITerminated

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68

Ascend Laboratories LLC

Failed Impurity/Degradation Specifications

December 17, 2020 · DrugView details →

Class IITerminated

Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88

Ascend Laboratories LLC

Failed Impurity/Degradation Specifications

December 17, 2020 · DrugView details →

Class IIITerminated

Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by Ndal Laboratories, 449 Alvarado St., Monterey, CA 93940 (bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8. the Alvarado St. is for the bottle by putting "(bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8." (according to the label)

NDAL Mfg Inc.

Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast

December 17, 2020 · DrugView details →

Class IITerminated

labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IITerminated

Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

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