Class III
Terminated
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, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6803-61
- Company
- The Harvard Drug Group
- Recall Initiated
- February 27, 2020
- Posted
- March 18, 2020
- Recall Number
- D-1001-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 115 cartons
- Firm Location
- Livonia, MI, United States
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.
Distribution
Nationwide
Lot / Code Info
Lot, expiry: Lot N00037, exp 05/2021
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