Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10...

FDA Drug Recall #D-0652-2022 — Class II — February 22, 2022

Recall Summary

Recall Number D-0652-2022
Classification Class II — Moderate risk
Date Initiated February 22, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm American Health Packaging
Location Columbus, OH
Product Type Drugs
Quantity 89,880 unit-dose cups

Product Description

Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40

Reason for Recall

Impurity failure at 0-time of the repackaged lot.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

Lot# 1004276, Exp 11/30/2022

Other Recalls from American Health Packaging

Recall # Classification Product Date
D-0880-2022 Class III Nitrofurantoin Capsules, USP (Monohydrate/Macro... May 3, 2022
D-0790-2022 Class III Cyanocobalamin Injection, USP, 1000 mcg per mL,... Apr 12, 2022
D-0451-2022 Class II Metoprolol Succinate Extended-Release Tablets, ... Dec 20, 2021
D-0020-2022 Class II GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 ... Sep 17, 2021
D-0854-2021 Class II Valproic Acid Oral Solution, USP, 500 mg/10 mL,... Sep 15, 2021

Frequently Asked Questions

Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.

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.