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Recall Observatory FDA recall evidence

Drug 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.

D-1257-2014

March 17, 2014

Class II

Product summary

Firm
John W Hollis Inc
Event
Event 67812
Status
Terminated
Classification
Class II
Quantity
7 vials
Official record key
drug-enforcement:D-1257-2014

Official wording

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

Code information: Lot #: 41652, Expiry: 8/2/14; Lot #: 41668, Expiry: 7/13/14

Distribution pattern: MO, TN, MS, WI

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect