Clopidogrel Tablets 75 mg Recalled for Manufacturing Quality Deviations
Preferred Pharmaceuticals is recalling Clopidogrel Tablets 75 mg nationwide due to manufacturing quality deviations found at manufacturer Accord Healthcare. The recall affects specific lot codes expiring October 2023.
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: This is a Class II pharmaceutical recall of a high-risk medication (antiplatelet agent) due to manufacturing practice deviations. Clopidogrel is a risk-of-harm product where improper manufacturing could affect product quality and patient safety. No illnesses or injuries have been reported.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Clopidogrel Tablets USP, 75 mg due to manufacturing quality deviations identified at Accord Healthcare, Inc., the contract manufacturer. The FDA inspection of the manufacturing facility revealed cGMP (current Good Manufacturing Practice) deviations.
The recall affects 72 bottles with lot codes E0922W, G1222E, I0922W, and K3022W, expiring October 31, 2023. The affected prescription medication was distributed nationwide in the United States and has an NDC number of 68788-8190-9.
Clopidogrel is an antiplatelet medication used to prevent blood clots in patients with cardiovascular disease. Manufacturing quality deviations could potentially impact the product's quality and safety. As of the recall announcement, no illnesses or injuries related to this product have been reported.
The recalled product
- Product
- Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Hazard
- manufacturing-deviation
- quality-control
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 (3)
- Lot: E0922W
- G1222E
- I0922W and K3022W Exp 10/31/2023.
Distribution
Distributed nationwide across the United States.
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