Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
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
Class I - Dangerous
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class I - Dangerous
Failed Impurity/Degradation Specifications
Class I - Dangerous
Failed Moisture Limits