Recalls / Class II
Class IID-0854-2018
Product
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
- Affected lot / code info
- Lot numbers: 180820005D, exp 6/21/2018; 180990007D, exp 7/8/2018; and 181000020D, exp 7/9/2018
Why it was recalled
Superpotent and Subpotent
Recalling firm
- Firm
- PharMEDium Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 36 Stults Rd, N/A, Dayton, New Jersey 08810
Distribution
- Quantity
- 2,800 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-06-05
- FDA classified
- 2018-06-08
- Posted by FDA
- 2018-06-20
- Terminated
- 2019-02-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0854-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.