Recalls / Class III
Class IIID-0843-2020
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.
- Affected lot / code info
- Lot Number: 9698818; labeled expiration AUG 2022; actual expiration APR 2022
Why it was recalled
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.
Recalling firm
- Firm
- Par Pharmaceutical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Ram Ridge Rd, Chestnut Ridge, New York 10977-6714
Distribution
- Quantity
- 9,936 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2020-02-10
- FDA classified
- 2020-02-13
- Posted by FDA
- 2020-02-19
- Terminated
- 2020-11-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0843-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.