PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01
Reported: August 27, 2014 Initiated: August 13, 2014 #D-1545-2014
Product Description
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01
Reason for Recall
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 56,060 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Melrose Park, IL
Frequently Asked Questions
What product was recalled? ▼
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01. Recalled by Fresenius Kabi USA, LLC. Units affected: 56,060 vials.
Why was this product recalled? ▼
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 27, 2014. Severity: Moderate. Recall number: D-1545-2014.
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