Why it was recalled
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: GH8254, Exp 06/19
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1179-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 25, 2017
- FDA report date
- Oct 4, 2017
- Quantity
- 13,435 shrink wrap packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-1179-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78169
- Address
- 100 College Rd W
- Code information
- Lot: GH8254, Exp 06/19
- Postal code
- 08540-6604
- Report date
- Oct 4, 2017
- Product type
- Drugs
- Recall number
- D-1179-2017
- Classification
- Class III
- Recalling firm
- Sandoz Inc
- Product quantity
- 13,435 shrink wrap packs
- Termination date
- Apr 8, 2019
- Reason for recall
- Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Sep 25, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 28, 2017