Recalls / Class III
Class IIID-0367-2022
Product
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30
- Affected lot / code info
- Lot: 375153 Exp. 10/31/2022
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
- 10,836 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-0367-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.