Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber P...

FDA Drug Recall #D-0248-2018 — Class III — January 22, 2018

Recall Summary

Recall Number D-0248-2018
Classification Class III — Low risk
Date Initiated January 22, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ascent Pharmaceuticals, Inc.
Location Central Islip, NY
Product Type Drugs
Quantity 45,875 bottles

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

Reason for Recall

Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol

Distribution Pattern

Nationwide

Lot / Code Information

Lot Numbers: 17080591 and 17080619, exp 07/19; 17110907 and 17110908, exp 10/19; and 17120986, exp 11/19

Other Recalls from Ascent Pharmaceuticals, Inc.

Recall # Classification Product Date
D-0276-2022 Class II Hydrocodone Bitartrate and Acetaminophen Tablet... Nov 19, 2021
D-0097-2021 Class II Hydrocodone Bitartrate and Acetaminophen Tablet... Oct 26, 2020

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.