Why it was recalled
Lack of sterility assurance.
Product description
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
U.S.A. Nationwide
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-0428-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 27, 2017
- FDA report date
- Feb 28, 2018
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0428-2018, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78828
- Address
- 150 N Field Dr Ste 350
- Code information
- All lots remaining within expiry.
- Postal code
- 60045-2506
- Report date
- Feb 28, 2018
- Product type
- Drugs
- Recall number
- D-0428-2018
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- Unknown
- Termination date
- May 7, 2020
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Dec 27, 2017
- Initial firm notification
- Press Release
- Center classification date
- Feb 20, 2018