Recalls / Class II
Class IID-0461-2018
Product
Neostigmine Methylsulfate Injection in all strengths, all doses, and all packaging.
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- Unknown
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2017-12-27
- FDA classified
- 2018-02-20
- Posted by FDA
- 2018-02-28
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0461-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.