Recalls / Class III
Class IIID-0132-2018
Product
HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
- Affected lot / code info
- Lot: 172410025C; Exp. 11/27/2017
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp. Date
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- Unknown
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2017-09-26
- FDA classified
- 2017-12-22
- Posted by FDA
- 2018-01-03
- Terminated
- 2020-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0132-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.