Recalls / Class II
Class IID-0287-2019
Product
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
- Brand name
- Quetiapine
- Generic name
- Quetiapine
- Active ingredient
- Quetiapine Fumarate
- Route
- Oral
- NDCs
- 67877-242, 67877-249, 67877-250, 67877-245, 67877-246, 67877-247, 67877-248
- FDA application
- ANDA201504
- Affected lot / code info
- Lot 7143908, exp Nov 2020
Why it was recalled
Presence of Foreign Substance; metal shard found in tablet
Recalling firm
- Firm
- Ascend Laboratories LLC
- Manufacturer
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-11-14
- FDA classified
- 2018-11-28
- Posted by FDA
- 2018-12-05
- Terminated
- 2020-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0287-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.