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Recall Observatory FDA recall evidence

Drug product

Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only. Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.

D-1258-2014

March 17, 2014

Class III

Product summary

Firm
John W Hollis Inc
Event
Event 67812
Status
Terminated
Classification
Class III
Quantity
1 vial
Official record key
drug-enforcement:D-1258-2014

Official wording

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

Code information: Lot #: 1905, Expiry: 4/30/14

Distribution pattern: MO, TN, MS, WI

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect