Drug product
Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34.
D-0843-2020
Product summary
- Event
- Event 84912
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,936 cartons
- Official record key
drug-enforcement:D-0843-2020
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
Code information: Lot Number: 9698818; labeled expiration AUG 2022; actual expiration APR 2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing