FindMyRecallSubscribe
Class III: unlikely to cause harmTerminated

Ascent Pharmaceuticals Oxycodone Hydrochloride Tablets Recall

Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured fo…

Ascent Pharmaceuticals, Inc. · Central Islip, NY

Risk level
Class III
Reported by FDA
Feb 7, 2018
Recall ID
D-0248-2018
Check your lot numberHow we source this data

Summary

Ascent Pharmaceuticals recalled Oxycodone Hydrochloride Tablets starting Jan 22, 2018. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0248-2018 on Feb 7, 2018. Reason: Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol. Status: Terminated.

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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0248-2018, published Feb 7, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls