Why it was recalled
Lack Of Assurance Of Sterility.
Product description
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17
Lot numbers, UPCs & expiration codes
Lot: 20170808@52 BUD: 11/06/2017
Where it was sold
Nationwide in the United States
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-0060-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 19, 2017
- FDA report date
- Nov 8, 2017
- Quantity
- 128 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0060-2018, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 78320
- Address
- 8821 Knoedl Ct
- Code information
- Lot: 20170808@52 BUD: 11/06/2017
- Postal code
- 72205-4600
- Report date
- Nov 8, 2017
- Product type
- Drugs
- Recall number
- D-0060-2018
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals, LLC
- Product quantity
- 128 syringes
- Termination date
- May 1, 2019
- Reason for recall
- Lack Of Assurance Of Sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17
- Distribution pattern
- Nationwide in the United States
- Recall initiation date
- Oct 19, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 2, 2017