Sandoz Recalls Ceftriaxone Sodium Vials Due to Missing Labels
Sandoz Inc is recalling 139,430 vials of Ceftriaxone Sodium for Injection in Wisconsin due to missing labels.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific defect is a missing label, which is a documentation/packaging issue.
Plain-English summary
Sandoz Inc is recalling 139,430 vials of Ceftriaxone Sodium for Injection, USP, 1 gram, 10 Single use Vials. The recall is due to a labeling issue where the product is missing labels. The affected product is identified by Sandoz Lot GJ7151 (Pfizer Lot 670028M) with an expiration date of 07/19.
The distribution pattern for this recall is limited to Wisconsin (WI). The product is a prescription-only medication intended for intramuscular or intravenous use. It was manufactured by Sandoz GmbH for Hospira Worldwide, Inc., and made in Austria.
Healthcare providers and patients should stop using the affected vials and contact their supplier or Sandoz Inc for further instructions. This recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- CEFTRIAXONE SODIUM (CEFTRIAXONE SODIUM)
- Brand
- CEFTRIAXONE SODIUM
- Manufacturer
- Sandoz Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 139,430
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 (2)
- Sandoz - Lot GJ7151(Pfizer- Lot 670028M)
- Exp. 07/19
Distribution
Distributed in 1 state:
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