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.
Product description
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, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61
Lot numbers, UPCs & expiration codes
Lot, expiry: Lot N00028, exp 04/2021; Lot N00044, exp 06/2021
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0999-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 27, 2020
- FDA report date
- Mar 18, 2020
- Quantity
- 330 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-0999-2020, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 85138
- Address
- 17177 N Laurel Park Dr Ste 233
- Code information
- Lot, expiry: Lot N00028, exp 04/2021; Lot N00044, exp 06/2021
- Postal code
- 48152-3951
- Report date
- Mar 18, 2020
- Product type
- Drugs
- Recall number
- D-0999-2020
- Classification
- Class III
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 330 cartons
- Termination date
- Sep 24, 2022
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 27, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 11, 2020