PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01

FDA recall notice · announced August 27, 2014 · Fresenius Kabi

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot 6007698, Exp. 03/16
Quantity: 56,060 vials
Status: Terminated
Products in this recall event:
- PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01 (D-1545-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.