Recalls / Class II
Class IID-0080-2018
Product
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
- Affected lot / code info
- Lot#: 172820134M, Exp 01/18
Why it was recalled
Superpotent drug: out of specification result for potency
Recalling firm
- Firm
- PharMEDium Services, LLC.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6100 Global Dr, N/A, Memphis, Tennessee 38141-8385
Distribution
- Quantity
- 499 syringes
- Distribution pattern
- CA, IL
Timeline
- Recall initiated
- 2017-10-13
- FDA classified
- 2017-11-14
- Posted by FDA
- 2017-11-22
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0080-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.