Recalls / Class II
Class IID-0044-2017
Product
glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.
- Affected lot / code info
- Lot Numbers: 15100141M, 15118066M, 15118083M, 15121090M, 15124001M, 15126042M, 15127036M, 15128030M, 15132065M, 15133010M, 15134007M, 15135010M, 15138062M, 15139002M, 15139003M, 15139052M, 15139053M, 15140083M, 15142002M, 15142090M, 15146084M, 15148044M, 15150014M, 15153002M, 151720016M, 151740133M, 151880151M, 151890120M, 151890239M, 151900019M, 151910015M, 151930042M, 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
- 16366 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-0044-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.