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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot Number: 9698818; labeled expiration AUG 2022; actual expiration APR 2022
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0843-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 10, 2020
- FDA report date
- Feb 19, 2020
- Quantity
- 9,936 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Pharmaceutical Inc.
Original FDA data
Every field from FDA enforcement report D-0843-2020, exactly as published.
Show all FDA fields
- City
- Chestnut Ridge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84912
- Address
- 1 Ram Ridge Rd
- Code information
- Lot Number: 9698818; labeled expiration AUG 2022; actual expiration APR 2022
- Postal code
- 10977-6714
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0843-2020
- Classification
- Class III
- Recalling firm
- Par Pharmaceutical Inc.
- Product quantity
- 9,936 cartons
- Termination date
- Nov 17, 2020
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 13, 2020