Recalls / Class III
Class IIID-1179-2017
Product
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.
- Brand name
- Ampicillin
- Generic name
- Ampicillin Sodium
- Active ingredient
- Ampicillin Sodium
- Route
- Intramuscular, Intravenous
- NDCs
- 0781-3400, 0781-3402, 0781-3407, 0781-3404, 0781-3408
- FDA application
- ANDA061395
- Affected lot / code info
- Lot: GH8254, Exp 06/19
Why it was recalled
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, N/A, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 13,435 shrink wrap packs
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-09-25
- FDA classified
- 2017-09-28
- Posted by FDA
- 2017-10-04
- Terminated
- 2019-04-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1179-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.