Recalls / Class II
Class IID-0987-2017
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
- Affected lot / code info
- Lots: a) 171320006S Exp. 8/13/2017, 171320014D Exp. 8/13/2017,171360020D Exp. 8/15/2017, 171520063D Exp. 8/31/2017; b) 171280054D Exp. 8/7/2017, 171320002D Exp. 8/10/2017, 171370005S Exp. 8/15/2017, 171440016D Exp. 8/23/2017, 171450012D Exp. 8/24/2017, 171510059D Exp. 8/30/2017, 171560027D Exp. 9/4/2017; c) 171170014S Exp. 7/27/2017, 171210127S Exp. 7/31/2017, 171230071D Exp. 8/2/2017, 171240002D Exp. 8/3/2017, 171240004D Exp. 8/3/2017, 171240191S Exp. 8/3/2017, 171280041D Exp. 8/7/2017, 171290077D Exp. 8/8/2017, 171300076D Exp. 8/9/2017, 171310058D Exp. 8/10/2017, 171320059D Exp. 8/13/2017, 171320190S Exp. 8/13/2017, 171360062D Exp. 8/15/2017, 171360068D Exp. 8/15/2017, 171380076D Exp. 8/17/2017, 171390064D Exp. 8/20/2017, 171390065D Exp. 8/20/2017, 171500064D Exp. 8/29/2017, 171530101S Exp. 9/3/2017, 171570058D Exp. 9/5/2017; d) 171210005S Exp. 7/30/2017, 171230008D Exp. 8/2/2017, 171500072D Exp. 8/29/2017, 171560028D Exp. 9/4/2017
Why it was recalled
Lack of Assurance of Sterility; media fill failure at manufacturer
Recalling firm
- Firm
- PharMedium Services, Llc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 12620 W Airport Blvd Ste 130, N/A, Sugar Land, Texas 77478-6200
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-06-26
- FDA classified
- 2017-07-14
- Posted by FDA
- 2017-07-26
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0987-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.