Recalls / Class II
Class IID-1165-2017
Product
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.
- Affected lot / code info
- Lots: 170850012C and 170850020C Exp. 06/25/17
Why it was recalled
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Recalling firm
- Firm
- PharMedium Services, Llc
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 12620 W Airport Blvd Ste 130, N/A, Sugar Land, Texas 77478-6200
Distribution
- Quantity
- 590 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-04-06
- FDA classified
- 2017-09-15
- Posted by FDA
- 2017-09-27
- Terminated
- 2020-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1165-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.