Reported Jul 10, 2024 · Terminated
Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by:…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606
Is this the product you have?
- Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only
- Mfg byCadila Healthcare Ltd., Ahmedabad, India
- Distributed by
Major Pharmaceutical 17177 N Laurel Park DrSuite 233LivoniaMI 48152USANDC 0904-7075-61
- UPC code309047075614
- Lot codes and dates
- Lot code
M04614Exp 09/30/2024
- Lot code
- Amount recalled
- 864 cartons
Where it was sold
- Nationwide
Why it was recalled
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
This product could cause temporary or reversible health problems — stop using it.
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