FDAFDA · Food and drugs·Recall number D-1000-2020
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, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6802-61
Published March 18, 2020 · Recall initiated: February 27, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- QUETIAPINE
- Manufacturer
- The Harvard Drug Group
- Distributor
- Nationwide
- Lot
- Lot, expiry: Lot N00036, exp 05/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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