Mylan Pharmaceuticals Inc: Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Phar
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Mylan Pharmaceuticals Inc
- Product
- Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.
- Reason / hazard
- Failed Dissolution Specifications
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide.
- Recall initiated
- 2026-07-24
- Code info
- Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Morgantown
- State
- WV
- Country
- United States
- Event id
- 99483
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