Why it was recalled
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Product description
15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
Lot numbers, UPCs & expiration codes
Lot #: 180040003D, Exp 3/18/18
Where it was sold
Product was distributed to SC, FL, NY, NY,WA
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-0422-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 5, 2018
- FDA report date
- Feb 21, 2018
- Quantity
- 24 Viaflex Bag
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PharMEDium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0422-2018, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79063
- Address
- 36 Stults Rd
- Code information
- Lot #: 180040003D, Exp 3/18/18
- Postal code
- 08810
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0422-2018
- Classification
- Class II
- Recalling firm
- PharMEDium Services, LLC
- Product quantity
- 24 Viaflex Bag
- Termination date
- Apr 24, 2018
- Reason for recall
- Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
- Distribution pattern
- Product was distributed to SC, FL, NY, NY,WA
- Recall initiation date
- Feb 5, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 29, 2018