Sandoz Recalls Ampicillin Vials Due to Missing Labels
Sandoz Inc is recalling 13,435 packs of Ampicillin for Injection because some vials are missing labels. The recall covers distribution in the USA and Puerto Rico.
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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a labeling defect (missing labels) rather than a contamination or safety hazard.
Plain-English summary
Sandoz Inc is recalling 13,435 shrink wrap packs of Ampicillin for Injection, USP, 500 mg per vial. The product is identified by Lot GH8254 with an expiration date of 06/19. The recall was initiated following a customer complaint that some vials within the shrink wrap packs were missing labels.
The affected product is distributed nationwide in the USA and Puerto Rico. It is a prescription-only medication manufactured in Austria by Sandoz GmbH or Sandoz Inc. The specific NDC codes for the single vial and 10-count shrink wrap packs are 0781-3407-78 and 0781-3407-95, respectively.
Healthcare providers and patients should stop using the affected product and contact Sandoz Inc for further instructions. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- AMPICILLIN (AMPICILLIN SODIUM)
- Brand
- AMPICILLIN
- Manufacturer
- Sandoz Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 13,435
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)
- Lot: GH8254
- Exp 06/19
Distribution
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