FDAClass IIINovember 9, 2016

Ramipril Capsules recall: Labeling Error

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.

Why was Ramipril Capsules recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.
Recalling firm
Actavis Laboratories, FL, Inc.
Quantity
15,984 bottles
Distribution
Nationwide and Puerto Rico
Recall date
November 9, 2016
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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