Fresenius Kabi Propranolol Hydrochloride Injection Recall

Why it was 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.

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

Lot numbers, UPCs & expiration codes

Lot 6007698, Exp. 03/16

Where it was sold

Nationwide and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1545-2014
Classification: Class II
Status: Terminated
Recall initiated: Aug 13, 2014
FDA report date: Aug 27, 2014
Quantity: 56,060 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Fresenius Kabi USA, LLC

Original FDA data

Every field from FDA enforcement report D-1545-2014, exactly as published.

Show all FDA fields

City: Melrose Park
State: IL
Status: Terminated
Country: United States
Event ID: 68910
Address: 2045 Cornell Ave
Code information: Lot 6007698, Exp. 03/16
Postal code: 60160-1002
Report date: Aug 27, 2014
Product type: Drugs
Recall number: D-1545-2014
Classification: Class II
Recalling firm: Fresenius Kabi USA, LLC
Product quantity: 56,060 vials
Termination date: May 24, 2016
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.
Voluntary / mandated: Voluntary: Firm initiated
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
Distribution pattern: Nationwide and Puerto Rico
Recall initiation date: Aug 13, 2014
Initial firm notification: Letter
Center classification date: Aug 19, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1545-2014, published Aug 27, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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