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
Reported: July 31, 2024 Initiated: June 21, 2024 #D-0617-2024
Product Description
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
Reason for Recall
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- a) 13,128 bottles; b) 252 bottles
- Distribution
- Nationwide within the United States
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: a) 13,128 bottles; b) 252 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 31, 2024. Severity: Moderate. Recall number: D-0617-2024.
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