Recalls / Class III
Class IIID-1002-2020
Product
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6804-61
- Brand name
- Quetiapine
- Generic name
- Quetiapine
- Active ingredient
- Quetiapine Fumarate
- Route
- Oral
- NDCs
- 0904-6801, 0904-6802, 0904-6803, 0904-6804, 0904-6805
- FDA application
- ANDA204203
- Affected lot / code info
- Lot, expiry: Lot N00037, exp 05/2021
Why it was recalled
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Recalling firm
- Firm
- The Harvard Drug Group
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, Livonia, Michigan 48152-3951
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-02-27
- FDA classified
- 2020-03-11
- Posted by FDA
- 2020-03-18
- Terminated
- 2022-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1002-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.