← FDA ENFORCEMENT
D-0550-2026Class III

AVEVA Drug Delivery Systems, Inc.

Recalling firm
AVEVA Drug Delivery Systems, Inc.
Product type
Drug
Status
Ongoing
Report date
2026-06-03
Distribution
Nationwide within the U.S
Firm state
FL
Product quantity
59,808 pouches (4,272 Individual Folding Carton (IFC))
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

Product description

Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.

Code / lot info

Lot #: 56841, Expires: 03/2028

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.