D-1280-2019 Class III Terminated

Recalled by Advantice Health — Cedar Knolls, NJ

FDA drug recall D-1280-2019 was initiated by Advantice Health on April 25, 2019 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated February 11, 2021). Affected quantity: 111,492 canisters total.

Recall Details

Product Type
Drugs
Report Date
May 8, 2019
Initiation Date
April 25, 2019
Termination Date
February 11, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
111,492 canisters total

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 14049A, Exp 12/21