FDA Drug Recalls

Recalls / Class II

Class IID-0221-2018

Product

Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20

Affected lot / code info
Lot #: 172560019M, Exp. 12/13/2017

Why it was recalled

Superpotent Drug

Recalling firm

Firm
Pharmedium Services, LLC
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506

Distribution

Quantity
2390 syringes
Distribution pattern
Nationwide within the US

Timeline

Recall initiated
2017-09-26
FDA classified
2018-01-12
Posted by FDA
2018-01-24
Terminated
2020-05-07
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0221-2018. 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