Originally published by our sister publication Infectious Disease Special Edition
This story was updated on July 17 due to an expansion of the recall.Sandoz has expanded their recall to another lot of cefazolin for injection for the same mispackaging error.
This is in addition to a voluntary recall on June 26 of one lot of cefazolin for injection, USP, 1 g per vial because a customer indicated that four vials labeled penicillin G potassium for injection, USP, 20 million units were incorrectly included in a carton (25 vials per carton) of the cefazolin carton.
There is reasonable probability that the inadvertent administration of penicillin G potassium injection 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, cardiac arrhythmias resulting from high potassium especially in patients with kidney impairment and delayed recovery, the recall message said.
However, Sandoz has not received any reports of adverse events or injuries related to the recall, according to the FDA. The company has received a complaint of inadvertent administration of the incorrect product to a patient.
| Product Name | Vial NDC | Carton NDC | Lot Number | Expiration Date | Manufacturer | Distributor |
|---|---|---|---|---|---|---|
| Cefazolin for injection, USP (25 by 1-g vials) | 0781-3451-70 | 0781-3451-96 | PG4360 | 2027-NOV | Sandoz GmbH | Sandoz Inc. |
| Penicillin G potassium for injection, USP | 0781-6136-94 | NA | PG4360 | 2027-NOV | Sandoz GmbH | Sandoz Inc. |
| Cefazolin for injection, USP (25 by 1-g vials) | 0781-3451-70 | 0781-3451-96 | PG4362 | 2027-NOV | Sandoz GmbH | Sandoz Inc. |
| Penicillin G potassium for injection, USP | 0781-6136-94 | NA | PG4362 | 2027-NOV | Sandoz GmbH | Sandoz Inc. |
Cefazolin for injection is used to treat infections caused by certain bacteria, including pneumonia. Cefazolin for injection, USP can also be used to prevent infections before and after surgery. Cefazolin for injection, USP is indicated for adult, older adult and pediatric patients, including newborn term infants.
Penicillin G 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, genital tract infections, anthrax, tetanus, gas gangrene, listeriosis, pasteurellosis, rat bite fever, fusospirochetosis, actinomycosis, complications in gonorrhea and syphilis, and Lyme disease. To reduce the development of drug-resistant bacteria and maintain effectiveness of penicillin G potassium and other antibacterial drugs, penicillin G should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Penicillin G is indicated for use in adults, adolescents, children, and newborn and preterm infants.
Although both cefazolin and penicillin G potassium belong to the beta-lactam group of antibiotics, they are indicated for different types of infections, and the spectrum of susceptible organisms also differs. Although the patient populations overlap, each medicine has specific on-label distinct groups, and the dosing regimens may differ.
Healthcare 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) 491-7872 or by email at sandoz6004@sedgwick.com.
For questions about the recall process, call Sedgwick at (844) 491-7872 between the hours of 8 a.m. and 5 p.m. EDT, Monday to Friday.
Please report any adverse reactions by calling Sandoz at (800) 525-8747. Customer service agents are available from 8:30 a.m. to 5 p.m. EDT, Monday to Friday, except on national holidays. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report online. Regular mail or fax: Download the form or call (800) 332-1088 to request a reporting form; submit by mail or fax to (800) FDA-0178.
