AvKARE: Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com,
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- AvKARE
- Product
- Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
- Reason / hazard
- Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the USA.
- Recall initiated
- 2026-02-13
- Code info
- Lot # 49261, Exp: 04/30/27
- Product quantity
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Pulaski
- State
- TN
- Country
- United States
- Event id
- 98449
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