Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31
Check against the official notice below — it lists the full affected range.
Dr. Reddy's Laboratories is recalling Clopidogrel Tablets, USP, 300 mg in 30-count blister packs due to failed dissolution specifications. During 18-month stability testing, two lots showed out-of-specification results for dissolution. The affected lots are T700423 (expiration 08/2019) and T800310 (expiration 03/2020). A total of 4,404 blister packs were distributed to four major distributors who supplied the product throughout the United States.
The recall involves a medication used to prevent blood clots. If the drug does not dissolve properly in the body, it may not work as intended. The source document does not specify what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Reason for recall: Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing. Distribution: Product was distributed to 4 major distributors who distributed the product throughout the United States. Quantity: 4,404 (30 count blister packs) Lot/code info: Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.