Stat Rx USA Recalls Venlafaxine ER Due to Labeling Error
Stat Rx USA is recalling 5 bottles of Venlafaxine ER 150mg because the label incorrectly identifies the dosage form as 'Tabs' instead of 'Capsules.'
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error regarding dosage form.
Plain-English summary
Stat Rx USA, LLC is recalling 5 bottles of Venlafaxine ER 150mg, 30 Tabs bottle, which is a generic for Effexor. The product was packaged and distributed by Stat Rx USA, LLC in Gainesville, GA. The specific lot number is A00984 with an expiration date of 01/14, and the NDC is 42549-684-30.
The recall was initiated due to a labeling error. The product was incorrectly labeled as 'Tabs' instead of 'Capsules.' This is a Class III recall, which indicates that the use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed in Georgia and Tennessee. Consumers who have this product should contact their pharmacist or healthcare provider for guidance on how to proceed.
The recalled product
- Product
- Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30
- Manufacturer
- Stat Rx USA
- Category
- Drug — Antidepressant
- Hazard
- Affected units
- 5
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 # A00984 Exp. 01/14
Distribution
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