Recalls / Class II
Class IID-0574-2021
Product
NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, 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
- 3006910
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 41 bottles
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0574-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.