Why it was recalled
Labeling: Missing Label
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 375153 Exp. 10/31/2022
Where it was sold
Nationwide USA
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-0367-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 3, 2021
- FDA report date
- Jan 19, 2022
- Quantity
- 10,836 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0367-2022, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 89142
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot: 375153 Exp. 10/31/2022
- Postal code
- 60045-4862
- Report date
- Jan 19, 2022
- Product type
- Drugs
- Recall number
- D-0367-2022
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 10,836 bottles
- Termination date
- Aug 19, 2022
- Reason for recall
- Labeling: Missing Label
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Dec 3, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2022