Recalls / Class II
Class IID-1473-2022
Product
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
- Brand name
- Neomycin Sulfate
- Generic name
- Neomycin Sulfate
- Active ingredient
- Neomycin Sulfate
- Route
- Oral
- NDC
- 0093-1177
- FDA application
- ANDA060304
- Affected lot / code info
- Lot #: 3007830, 3007746, 3007829, Exp. Date 10/2024
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-08-23
- FDA classified
- 2022-08-30
- Posted by FDA
- 2022-09-07
- Terminated
- 2023-09-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1473-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.