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
ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
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: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409
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
Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
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
ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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
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
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
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit