FDA Recall D-0118-2017

Actavis Laboratories, FL, Inc. · Davie, FL

Class III Ongoing 3544 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

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

Quantity: 15,984 bottles

Reason for recall

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

Recall record

Recall number: D-0118-2017
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide and Puerto Rico
Recall initiated: 2016-08-30
Classified by FDA Center: 2016-11-01
FDA published: 2016-11-09
Recalling firm: Actavis Laboratories, FL, Inc.
Firm location: Davie, FL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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