Recalls / Class II
Class IID-0075-2017
Product
midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.
- Affected lot / code info
- Lot Numbers: 151170045M, 151170084M, 151170093M, 15117084M, 151180080M, 15118092M, 15118094M, 15119054M, 15120072M, 15121093M, 151240093M, 151240094M, 151240099M, 15124074M, 151250094M, 15126044M, 15126079M, 15126080M, 15127097M, 15127098M, 15128112M, 151310092M, 151310103M, 151310105M, 15131028M, 151320099M, 15133012M, 15133081M, 15134068M,15134069M, 151380068M, 151380106M, 151380112M, 151390138M, 15139090M, 15140088M, 15140089M, 15141045M, 15141074M, 15141075M, 151450030M, 151450032M, 151460097M, 15146083M, 15146087M, 15149001M, 15149005M, 15149118M, 15149119M, 15150104M, 15152056M, 151720012M, 151730078M, 151730138M, 151740019M, 151740141M, 151740143M, 151890127M, 151890128M, 151890305M, 151900021M, 151900022M, 151900140M, 151930073M, 151930171M, 151930173M, Exp between 07/15/15-10/12/15
Why it was recalled
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 26079 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-17
- FDA classified
- 2016-10-12
- Posted by FDA
- 2016-10-19
- Terminated
- 2017-06-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0075-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.