Recalls / Class II
Class IID-0060-2018
Product
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
- Affected lot / code info
- Lot: 20170808@52 BUD: 11/06/2017
Why it was recalled
Lack Of Assurance Of Sterility.
Recalling firm
- Firm
- SCA Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, N/A, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- 128 syringes
- Distribution pattern
- Nationwide in the United States
Timeline
- Recall initiated
- 2017-10-19
- FDA classified
- 2017-11-02
- Posted by FDA
- 2017-11-08
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0060-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.