Recalls / Class II
Class IID-0079-2017
Product
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3259.
- Affected lot / code info
- Lot Numbers: 15125021M, 15126043M, 15126064M, 15126065M, 15126066M, 15127091M, 15132014M, 15133011C, 15134006C, 15134007C, 15134062M, 15135063M, 15139087M, 15141002C, 15141040M, 15141041M, 15146081M, 15147036M, 15147037M, 15147122M, 15148003C, 15148012M, 15148119M, 15149003M, 15152004C, 15153006C, 15154002C, 15155007C, 15160009C, 151650003C 151660005C, 151660006C, 151670005C, 151720005C, 151720041C, 151730003M, 151730006C, 151730007C, 151730128M, 151740131M, 151740136M, 151750007C, 151790041C, 151930021M, 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
- 21506 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-0079-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.