Recalls / Class II
Class IID-0077-2017
Product
morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.
- Affected lot / code info
- Lot Numbers: 15117038M, 151200111M, 15126052M, 15127038M, 15131015M, 15134028M, 15134031M, 15135049M, 151380104M, 15139033M, 15139063M, 151410121M, 15146038M, 15147041M, 15149045M, 15152036M, 151730212M, 151890291M, 151930131M, Exp between 07/15/15-10/12/15
Why it was recalled
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 935 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-17
- FDA classified
- 2016-10-12
- Posted by FDA
- 2016-10-19
- Terminated
- 2017-06-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0077-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.