FDAFDA · Food and drugs·Recall number D-0287-2019
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1
Published December 5, 2018 · Recall initiated: November 14, 2018
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
Presence of Foreign Substance; metal shard found in tablet
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- QUETIAPINE
- Manufacturer
- Ascend Laboratories LLC
- Distributor
- Nationwide
- UPC
- 367877248011
- Lot
- Lot 7143908, exp Nov 2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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