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Recall Observatory FDA recall evidence

Drug product

Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.

D-0118-2017

August 30, 2016

Class III

Product summary

Firm
Actavis Laboratories, FL, Inc.
Event
Event 75042
Status
Ongoing
Classification
Class III
Quantity
15,984 bottles
Official record key
drug-enforcement:D-0118-2017

Official wording

Reason: Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.

Code information: Lot #: 1136091A, Incorrectly Labeled Exp: 03/18

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing