Recalls / Class III
Class IIID-0354-2023
Product
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
- Brand name
- Gabapentin
- Generic name
- Gabapentin
- Active ingredient
- Gabapentin
- Route
- Oral
- NDCs
- 50228-177, 50228-178
- FDA application
- ANDA205101
- Affected lot / code info
- Lot # G177092, Exp. 11/24
Why it was recalled
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Recalling firm
- Firm
- Sciegen Pharmaceuticals Inc
- Manufacturer
- ScieGen Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 89 Arkay Dr, N/A, Hauppauge, New York 11788-3727
Distribution
- Quantity
- 4,392 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2023-02-17
- FDA classified
- 2023-02-27
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0354-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.