Recalls / Class II
Class IID-0045-2017
Product
glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3329.
- Affected lot / code info
- Lot Numbers: 15117086M, 15117087M, 15117088M, 15118090M, 15120069M, 15120070M, 15124086M, 15126074M, 15126075M, 15127031M, 15127095M, 15133009M, 15133079M, 15134011M, 15134022M, 15134065M, 15140004M, 15140046M, 15140086M, 15141022M, 15141023M, 15141042M, 15142094M, 15147098M, 15149114M, 15149115M, 151520082M, 151520100M, 151520101M, 151520102M, 15152054M, 151740174M, 151880153M, 151890124M, 151900020M, 151910018M, 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
- 17462 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-0045-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.