Why it was recalled
Presence of Foreign Substance; metal shard found in tablet
Product description
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
Lot numbers, UPCs & expiration codes
Lot 7143908, exp Nov 2020
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-0287-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 14, 2018
- FDA report date
- Dec 5, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-0287-2019, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81568
- Address
- 339 Jefferson Rd Ste 101
- Code information
- Lot 7143908, exp Nov 2020
- Postal code
- 07054-3707
- Report date
- Dec 5, 2018
- Product type
- Drugs
- Recall number
- D-0287-2019
- Classification
- Class II
- Recalling firm
- Ascend Laboratories LLC
- Termination date
- Mar 30, 2020
- Reason for recall
- Presence of Foreign Substance; metal shard found in tablet
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 14, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 28, 2018