Recalls / Class II
Class IID-1084-2020
Product
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44
- Affected lot / code info
- 193510022D 3/17/2020 193510023D 3/17/2020 193580012D 3/25/2020 193600013D 3/26/2020 193640016D 3/30/2020 193530020D 3/19/2020 193540023D 3/22/2020 193540026D 3/22/2020
Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recalling firm
- Firm
- PharMEDium Services, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 36 Stults Rd, N/A, Dayton, New Jersey 08810
Distribution
- Quantity
- 1840 units
- Distribution pattern
- Distributed Nationwide in the US
Timeline
- Recall initiated
- 2020-03-16
- FDA classified
- 2020-04-06
- Posted by FDA
- 2020-04-15
- Terminated
- 2025-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1084-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.