Why it was recalled
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Product description
Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01
Lot numbers, UPCs & expiration codes
Lot #: 3007830, 3007746, 3007829, Exp. Date 10/2024
Where it was sold
Nationwide within the United States
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-1473-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2022
- FDA report date
- Sep 7, 2022
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-1473-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90792
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #: 3007830, 3007746, 3007829, Exp. Date 10/2024
- Postal code
- 07054-1120
- Report date
- Sep 7, 2022
- Product type
- Drugs
- Recall number
- D-1473-2022
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Termination date
- Sep 7, 2023
- Reason for recall
- CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 23, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 30, 2022