Zydus Pharmaceuticals USA Inc: 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-

Is my product affected?

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. Penning

• Brand VENLAFAXINE HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

Zydus Pharmaceuticals USA Inc is recalling Venlafaxine HCL ER Capsule USP 150mg due to failed dissolution specifications. The affected medication was distributed nationwide in three bottle sizes: 30-count bottles (NDC 68382-036-06), 90-count bottles (NDC 68382-036-16), and 1000-count bottles (NDC 68382-036-26). A total of 223,776 bottles are involved in this recall. Multiple lot numbers are affected with expiration dates ranging from September 2017 through November 2017, including lots MR10518, MR11051, MR11052, MR11053, MR11054, MR11403, MR10197, MR10195, MR11482, MR11479, MR11480, MR11481, MR11483, MR11665, MR10404, MR10406, MR10521, MR10744, MR11055, MR11228, MR11287, MR11285, MR11288, MR11289, MR11286, and MR11567.

The recall was initiated because retained samples showed out-of-specification dissolution results, meaning the medication did not dissolve properly in the body as intended. The source document does not specify a remedy or instructions for affected consumers to follow.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed Dissolution Specifications: out of specification dissolution results in retained samples

Details from the source

Reason for recall: Failed Dissolution Specifications: out of specification dissolution results in retained samples Distribution: Nationwide Quantity: 223,776 bottles Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (2016-07-29
• COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (2016-07-29
• 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.2016-07-29
• Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.2016-04-06
• Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.2016-04-06

All FDA (Drug enforcement) recalls