Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.
Reported: August 24, 2016 Initiated: July 19, 2016 #D-1460-2016
Product Description
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.
Reason for Recall
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 223,776 bottles
- Distribution
- Nationwide
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 223,776 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 24, 2016. Severity: Moderate. Recall number: D-1460-2016.
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