Venlafaxine Hydrochloride Extended-Release Capsules recall: Failed Dissolution
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
Why was Venlafaxine Hydrochloride Extended-Release Capsules recalled?
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
- Product
- Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Quantity
- a) 13,128 bottles; b) 252 bottles
- Distribution
- Nationwide within the United States
- Recall date
- July 31, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)