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Recall Observatory FDA recall evidence

Drug product

Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.

D-1031-2016

May 19, 2016

Class III

Product summary

Firm
Galderma Laboratories, L.P.
Event
Event 74209
Status
Terminated
Classification
Class III
Quantity
71,340 Bottles
Official record key
drug-enforcement:D-1031-2016

Official wording

Reason: Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.

Code information: Lot #: 1496059A, Expiry: 08/31/2017; Lot #: AD9848A, Expiry: 11/30/2017

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect Or Missing