Sandoz cefazolin cartons contained vials labeled as penicillin G potassium
Sandoz Cefazolin for Injection 1 gram is being recalled after cartons were found to contain vials labeled as penicillin G potassium. 208,300 vials are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
Cefazolin for Injection, USP, 1 gram per vial, sterile, for intramuscular or intravenous use, prescription only, manufactured by Sandoz GmbH for Sandoz Inc. of Princeton, New Jersey, NDC 0781-3451-70 for the vial and 0781-3451-96 for the carton, is being recalled. The action covers 208,300 vials.
The stated reason is a label mix-up: cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as Penicillin G Potassium for Injection, USP, 20 million Units. According to the notice, the vials contained cefazolin. The FDA classified the action as Class I, its most serious classification.
Affected lots are PG4360 and PG4362, expiring 11/30/2027. Distribution was nationwide in the USA. The vials are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the NDCs and lot numbers above, quarantine it, and follow the instructions issued by Sandoz.
The recalled product
- Product
- CEFAZOLIN (CEFAZOLIN)
- Brand
- CEFAZOLIN
- Manufacturer
- Sandoz Inc
- Category
- Drug — Injectable antibiotic
- Affected units
- 208,300
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # PG4360
- PG4362
- Exp. 11/30/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Sandoz Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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