Recalls / Class II
Class IID-1150-2015
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.
- Affected lot / code info
- Lot # P-20000; Exp. 08/16 Lot # P-20004; Exp. 08/16
Why it was recalled
Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
Recalling firm
- Firm
- The Harvard Drug Group, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 31778 Enterprise Dr, Livonia, Michigan 48150-1960
Distribution
- Quantity
- 12,717 tablets
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-06-10
- FDA classified
- 2015-06-29
- Posted by FDA
- 2015-07-08
- Terminated
- 2016-09-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1150-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.