Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Onl...
FDA Drug Recall #D-0843-2020 — Class III — February 10, 2020
Recall Summary
| Recall Number | D-0843-2020 |
| Classification | Class III — Low risk |
| Date Initiated | February 10, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Par Pharmaceutical Inc. |
| Location | Chestnut Ridge, NY |
| Product Type | Drugs |
| Quantity | 9,936 cartons |
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.
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.
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Lot Number: 9698818; labeled expiration AUG 2022; actual expiration APR 2022
Other Recalls from Par Pharmaceutical Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1542-2020 | Class II | BusPIRone Hydrochloride Tablets, USP 7.5 mg ND... | Aug 10, 2020 |
| D-1071-2020 | Class II | Glycopyrrolate Tablets, USP 1 mg, 100-count bot... | Mar 30, 2020 |
| D-1035-2020 | Class III | PrediniSONE Tablets, USP 5 mg, 48-count bottle,... | Mar 4, 2020 |
| D-0234-2016 | Class III | Meclizine Hydrochloride Tablets USP, 25 mg Tabl... | Oct 26, 2015 |
| D-0233-2016 | Class III | Meclizine Hydrochloride Tablets, USP, 12.5 mg T... | Oct 26, 2015 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.