The Recall Desk
CriticalFDA (Drugs)·D-1361-2014·Announced 2014-06-18

Greenstone Recalls Venlafaxine Capsules Due to Foreign Capsule Contamination

Greenstone LLC is recalling 16,018 bottles of Venlafaxine HCl Extended-Release Capsules because a foreign capsule was found in a bottle from the same packaging campaign.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Greenstone LLC is recalling 16,018 bottles of Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles. The product is identified by NDC 59762-0182-2 and UPC 3 59762-0182-2 9. The specific lot code is V130014 with an expiration date of 08/15.

The recall was initiated after a report of a foreign capsule with markings (TKN 250) was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules. The foreign capsule was identified as a Tikosyn (dofetilide) capsule. This incident occurred in a bottle packaged in the same packaging campaign as the recalled lot.

The affected product was distributed nationwide and in Puerto Rico. Consumers should check their medication for the specific lot code and expiration date listed above. If the product matches the recalled lot, consumers should stop using it and contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
Manufacturer
Greenstone Llc
Affected units
16,018

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • V130014
  • Exp 08/15

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: