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Recall Observatory FDA recall evidence

Drug product

Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7.

D-1280-2019

April 25, 2019

Class III

Product summary

Firm
Advantice Health
Event
Event 82709
Status
Terminated
Classification
Class III
Quantity
111,492 canisters total
Official record key
drug-enforcement:D-1280-2019

Official wording

Reason: Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.

Code information: Lot #: 14049A, Exp 12/21

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.