Why it was recalled
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Product description
Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52.
Lot numbers, UPCs & expiration codes
Lots: 170850012C and 170850020C Exp. 06/25/17
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-1165-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 6, 2017
- FDA report date
- Sep 27, 2017
- Quantity
- 590 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PharMedium Services, Llc
Original FDA data
Every field from FDA enforcement report D-1165-2017, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77856
- Address
- 12620 W Airport Blvd Ste 130
- Code information
- Lots: 170850012C and 170850020C Exp. 06/25/17
- Postal code
- 77478-6200
- Report date
- Sep 27, 2017
- Product type
- Drugs
- Recall number
- D-1165-2017
- Classification
- Class II
- Recalling firm
- PharMedium Services, Llc
- Product quantity
- 590 bags
- Termination date
- Jan 13, 2020
- Reason for recall
- Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 6, 2017
- Initial firm notification
- Telephone
- Center classification date
- Sep 15, 2017