Par Pharmaceutical Recalls Frovatriptan Tablets Due to Incorrect Expiration Date
Par Pharmaceutical is recalling 9,936 cartons of Frovatriptan Succinate Tablets, 2.5mg, because they are labeled with an incorrect expiration date.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding the expiration date.
Plain-English summary
Par Pharmaceutical Inc. is recalling 9,936 cartons of Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton. The product is identified by NDC 0603-3718-34 and Lot Number 9698818. The tablets were manufactured by Almac Pharma Services Limited in the UK for Par Pharmaceutical in Chestnut Ridge, NY.
The recall was initiated because the product is incorrectly labeled with an expiration date of August 2022, whereas the correct expiration date is April 2022. This is a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.
The affected product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for credit or disposal, as directed by the recalling firm.
The recalled product
- 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.
- Manufacturer
- Par Pharmaceutical Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 9,936
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Number: 9698818
- labeled expiration AUG 2022
- actual expiration APR 2022
Distribution
Distributed nationwide across the United States.
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