FDA Drug Recalls

Recalls / Class II

Class IID-0592-2016

Product

Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Affected lot / code info
All lots with expiration dates up to 11/17/2015

Why it was recalled

Stability data does not support expiry.

Recalling firm

Firm
Pharmakon Pharmaceuticals
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
14450 Getz Rd, N/A, Noblesville, Indiana 46060-3303

Distribution

Quantity
2750
Distribution pattern
Nationwide

Timeline

Recall initiated
2015-08-19
FDA classified
2016-01-27
Posted by FDA
2016-02-03
Terminated
2017-05-09
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0592-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls