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, Distribut

FDA recall notice · announced August 24, 2016 · Zydus Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Notes

Distribution: Nationwide
Lot/code information: Lot #: a) MR10518, Exp. 9/2017; MR11051, MR11052, MR11053, MR11054, Exp. 10/2017; MR11403, Exp. 11/2017. Lot #: b) MR10197, MR10195, Exp. 09/2017; MR11482, Exp.10/2017; MR11479, MR11480, MR11481, MR11483, MR11665 Exp. 11/2017. Lot #: c) MR10404, MR10406, MR10521, Exp. 09/2017; MR10744, MR11055, MR11228, MR11287, MR11285, MR11288, MR11289, MR11286, Exp.10/2017; MR11567, Exp.11/2017.
Quantity: 223,776 bottles
Status: Terminated
Products in this recall event:
- Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured b (D-1461-2016)
- 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 (D-1460-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.