FDA MedWatch - One Additional Lot of Cefazolin for Injection by Sandoz

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TOPIC: One Additional Lot of Cefazolin for Injection by Sandoz: Recall Expansion - Due to Vials Being Potentially Mislabeled as Penicillin G Potassium for Injection

AUDIENCE: Patient, Health Professional, Pharmacy, Internal Medicine, Infectious Disease

ISSUE: Sandoz, Inc. is initiating a nationwide recall expansion of one additional lot of Cefazolin for Injection USP, 1 gram per vial due to a customer complaint indicating that four (4) vials incorrectly labelled as Penicillin G Potassium for Injection USP, 20 million units were included in cartons (25 vials per carton) of Cefazolin for Injection USP, 1 gram per vial product. Sandoz has confirmed that the vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection USP, 1 gram per vial.

Risk Statement: There is a reasonable probability that the inadvertent administration of cefazolin injection following dosing recommendation of Penicillin G Potassium Injection due to mislabeling may pose serious and potentially life-threatening adverse health consequences, including lack of efficacy leading to less than optimal treatment of severe infections, antibiotic resistance, adverse reactions, severe allergic reactions (e.g., anaphylaxis), drug interactions, and delayed recovery.

The product being recalled was shipped to select wholesalers for further distribution nationwide. 

To date, Sandoz has not received any reports of adverse events or injuries related to the product mislabeling. Sandoz has received a complaint of administration of the incorrectly labelled product to a patient.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND:

• Cefazolin for Injection USP is used for the treatment of infections caused by certain bacteria in many different parts of the body including the treatment of pneumonia.

• Penicillin G Potassium for Injection is indicated in the treatment of certain serious infections including septicemia, skin and wound infections. It is also approved for the treatment of diphtheria, community-acquired pneumonia, peritonitis, meningitis/brain abscesses, osteomyelitis, infections of the genital tract, anthrax, tetanus, gas gangrene, listeriosis, pasteurellosis, rat bite fever, fusospirochetes, actinomycosis, complications in gonorrhea and syphilis and Lyme. 

RECOMMENDATIONS: 

• Health care providers and customers who have this product should immediately stop use of this lot only and contact Sedgwick, the Sandoz Reverse Distributor, directly by phone at (844) 265-7409 or by email at Sandoz5615@sedgwick.com.

• For questions about the recall process, please call Sedgwick at (844) 265-7409.

• Please report any adverse reactions by calling Sandoz at (800) 525-8747. 

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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