Recalls / Class II
Class IID-1111-2022
Product
Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx only, MFG: Sun Pharmaceuticals, NDC 62756-522-69
- Brand name
- Sumatriptan Succinate
- Generic name
- Sumatriptan Succinate
- Active ingredient
- Sumatriptan Succinate
- Route
- Oral
- NDCs
- 62756-520, 62756-521, 62756-522
- FDA application
- ANDA078295
- Affected lot / code info
- McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Why it was recalled
cGMP deviations: Temperature abuse
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 1 carton/9 blister packs
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2022-04-13
- FDA classified
- 2022-06-09
- Posted by FDA
- 2022-06-15
- Terminated
- 2023-11-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1111-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.