Ascend Recalls Quetiapine Tablets Due to Metal Shard Contamination
Ascend Laboratories is recalling Quetiapine 400 mg tablets because a metal shard was found in a tablet. Patients should stop using the affected lot and contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a physical foreign substance (metal shard) in a medication, which poses a risk of harm (injury) even though no specific injuries are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ascend Laboratories LLC is recalling Quetiapine Tablets USP 400 mg, 100 tablet bottles, due to the presence of a foreign substance. Specifically, a metal shard was found in a tablet from Lot 7143908, which has an expiration date of November 2020.
The affected product is manufactured by Alkem Laboratories Ltd. in Mumbai, India, and distributed by Ascend Laboratories LLC in Parsippany, NJ. The recall is nationwide. The product is identified by NDC 67877-248-01 and UPC code 3 67877-248-01 1.
Patients and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be stopped and returned to the pharmacy or distributor. Patients should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- QUETIAPINE (QUETIAPINE)
- Brand
- QUETIAPINE
- Manufacturer
- Ascend Laboratories LLC
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 7143908
- exp Nov 2020
UPCs (1)
- 367877248011
Distribution
Distributed nationwide across the United States.
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