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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Category
- Drug — Prescription Medication
- 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
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