Why it was recalled
Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # P-20000; Exp. 08/16 Lot # P-20004; Exp. 08/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1150-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 10, 2015
- FDA report date
- Jul 8, 2015
- Quantity
- 12,717 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group, LLC
Original FDA data
Every field from FDA enforcement report D-1150-2015, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 71454
- Address
- 31778 Enterprise Dr
- Code information
- Lot # P-20000; Exp. 08/16 Lot # P-20004; Exp. 08/16
- Postal code
- 48150-1960
- Report date
- Jul 8, 2015
- Product type
- Drugs
- Recall number
- D-1150-2015
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group, LLC
- Product quantity
- 12,717 tablets
- Termination date
- Sep 12, 2016
- Reason for recall
- Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 10, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2015