Recalls / Class III
Class IIID-0368-2022
Product
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34
- Affected lot / code info
- Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023
Why it was recalled
Labeling: Missing Label
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 8184 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-12-03
- FDA classified
- 2022-01-13
- Posted by FDA
- 2022-01-19
- Terminated
- 2022-08-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0368-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.