Why it was recalled
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Product description
Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01
Lot numbers, UPCs & expiration codes
Lot Numbers: 17080591 and 17080619, exp 07/19; 17110907 and 17110908, exp 10/19; and 17120986, exp 11/19
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-0248-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 22, 2018
- FDA report date
- Feb 7, 2018
- Quantity
- 45,875 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascent Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0248-2018, exactly as published.
Show all FDA fields
- City
- Central Islip
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 78990
- Address
- 550 S Research Pl
- Code information
- Lot Numbers: 17080591 and 17080619, exp 07/19; 17110907 and 17110908, exp 10/19; and 17120986, exp 11/19
- Postal code
- 11722-4415
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0248-2018
- Classification
- Class III
- Recalling firm
- Ascent Pharmaceuticals, Inc.
- Product quantity
- 45,875 bottles
- Termination date
- Apr 23, 2018
- Reason for recall
- Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 22, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 1, 2018