Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Princeton, NJ — Sandoz Inc. has declared an extension of its voluntary nationwide recall of Cefazolin for Injection, USP (1 gram per vial) due to a significant labeling mistake that may lead to life-threatening health hazards.
This expansion encompasses an additional lot after it was found that vials marked as Penicillin G Potassium for Injection were incorrectly packaged with Cefazolin.
The lots affected are PG4360 and PG4362, which were distributed across the country to wholesalers. Sandoz confirmed the labeling error after a customer reported four mislabeled vials in one carton. The company has verified that the vials in question contained Cefazolin instead of Penicillin G.
Health Risk Warning
Sandoz and the FDA are urging healthcare providers to immediately stop using the affected lots. Administering Cefazolin instead of Penicillin G — or vice versa — based on incorrect labeling can result in serious, potentially fatal consequences, such as:
- Improper treatment of infections due to incorrect drug use
- Increased risk of antibiotic resistance
- Severe allergic reactions, including anaphylaxis
- Delayed recovery and treatment failure
- Possible drug interactions
While there have been no reported negative health incidents up to this point, Sandoz has recognized a case of improper drug administration due to mislabeling.
Products Affected
Product Name Lot Number Expiration Date:
- Cefazolin for Injection, USP (25x1g) PG4360 NOV 2027
- Cefazolin for Injection, USP (25x1g) PG4362 NOV 2027
- Penicillin G Potassium for Injection PG4360 NOV 2027
- Penicillin G Potassium for Injection PG4362 NOV 2027
Both antibiotics belong to the beta-lactam class, yet they target different bacterial infections and necessitate unique dosing schedules. Cefazolin is generally employed to address infections such as pneumonia and for surgical prophylaxis, whereas Penicillin G is used for more serious or specific ailments like septicemia, meningitis, anthrax, and syphilis.
Recall Procedure
Sandoz is notifying customers via letter and arranging returns of the affected lots. Customers and healthcare providers are instructed to:
- Stop using the affected lots immediately
- Contact Sedgwick, the company’s reverse distributor, at (844) 265-7409 or Sandoz5615@sedgwick.com for recall instructions
- Report any adverse reactions to Sandoz at (800) 525-8747 or to the FDA MedWatch program at www.fda.gov/medwatch/report.htm
- This recall is being conducted with the full knowledge and oversight of the U.S. Food and Drug Administration (FDA).
About Sandoz
Sandoz (SIX: SDZ; OTCQX: SDZNY), a global leader in generic and biosimilar medicines, delivers more than 900 million patient treatments annually across 100 countries. With a history dating back to 1886, Sandoz has pioneered breakthroughs including the first oral penicillin and the first biosimilar medicine. In 2024, the company reported net sales of $10.4 billion.
For more information or updates on this recall, visit www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.
