McKesson Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failure
McKesson Packaging Services is recalling 1,557 boxes of Venlafaxine Hydrochloride Extended Release Capsules, 150 mg, due to out-of-specification dissolution results.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
McKesson Packaging Services is recalling 1,557 boxes of Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, NDC 63739-0512-10. The product is manufactured by Teva Pharmaceuticals USA and was distributed nationwide. The recall is limited to Lot # 91357.
The recall was initiated because the product failed to meet dissolution specifications, specifically showing out-of-specification results at the 12-month interval. This indicates that the medication may not release the active ingredient as intended over time.
The U.S. Food and Drug Administration has classified this recall as Class III. This classification indicates that the product is not likely to cause adverse health consequences or death. Consumers and healthcare providers should contact McKesson Packaging Services or their pharmacy for further instructions on how to handle the affected medication.
The recalled product
- Product
- Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10
- Manufacturer
- McKesson Packaging Services
- Category
- Drug — Antidepressant
- Hazard
- Affected units
- 1,557
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 (1)
- Lot #: 91357
Distribution
Distributed nationwide across the United States.
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