Quetiapine Fumarate Extended-Release Tablets, 150 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 U

FDA recall notice · announced March 18, 2020 · The Harvard Drug Group

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Quetiapine Fumarate Extended-Release Tablets, 150 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: 0904-6802-61

Reason for recall

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Notes

Distribution: Nationwide
Lot/code information: Lot, expiry: Lot N00036, exp 05/2021
Quantity: 1 carton
Status: Terminated
Products in this recall event:
- 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, 1 (D-1002-2020)
- Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 1 (D-1001-2020)
- Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17 (D-0999-2020)
- Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 1 (D-1000-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.