Recalls / Class II
Class IID-0125-2017
Product
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
- Affected lot / code info
- Lot #: 162790012M, Exp. 1/3/2017
Why it was recalled
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 1550 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-10-12
- FDA classified
- 2016-11-03
- Posted by FDA
- 2016-11-09
- Terminated
- 2016-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0125-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.