FDA Drug Recalls

Recalls / Class II

Class IID-1257-2014

Product

Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.

Affected lot / code info
Lot #: 41652, Expiry: 8/2/14; Lot #: 41668, Expiry: 7/13/14

Why it was recalled

Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.

Recalling firm

Firm
John W Hollis Inc
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
110 20th Ave N, Nashville, Tennessee 37203-2315

Distribution

Quantity
7 vials
Distribution pattern
MO, TN, MS, WI

Timeline

Recall initiated
2014-03-17
FDA classified
2014-04-25
Posted by FDA
2014-05-07
Terminated
2014-05-01
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1257-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.