Recalls / Class II
Class IID-0082-2017
Product
neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326.
- Affected lot / code info
- Lot Numbers: 15112030M, 15112033M, 15112034M, 15112099M, 15112101M, 15112103M, 15112105M, 15112108M, 15113001M, 15113002M, 15113003M, 15113007M, 15113032M, 15113033M, 15113075M, 15113076M, 15159002S, 15159003S, 15159004S, 15159006S, 15159007S, 15159009S, 15159011S, 15174213S, 15175035S, 15175036S, 15175037S, 15176015S, 15176016S, 15176017S, 15176018S, 15176020S, 15176021S, 15176022S, 15176024S, 15177011S, 15177012S, 15177013S, 15177016S, 15177017S, 15177018S, 15177019S, 15180245S, 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
- 21053 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-0082-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.