Why it was recalled
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Product description
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0079-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2015
- FDA report date
- Oct 19, 2016
- Quantity
- 21506 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0079-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 73925
- Address
- 150 N Field Dr Ste 350
- Code information
- 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
- Postal code
- 60045-2506
- Report date
- Oct 19, 2016
- Product type
- Drugs
- Recall number
- D-0079-2017
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 21506 syringes
- Termination date
- Jun 23, 2017
- Reason for recall
- Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 17, 2015
- Initial firm notification
- Center classification date
- Oct 12, 2016