FDA recall D-1150-2015

The Harvard Drug Group, LLC · Class II · drug

Product

OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63044, Distributed by Major Pharmaceuticals, Livonia, MI 48150, NDC 0904-6444-61.

Reason for recall

Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-06-10
Report date: 2015-07-08
Termination date: 2016-09-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1150-2015