Drug recall D-0592-2021
Product
Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
395310
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 271 bottles
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Amantadine Hydrochloride – drug information
- NDC 0832-0111 Amantadine Hydrochloride · Amantadine Hydrochloride 100 mg/1 · Upsher-Smith Laboratories, LLC