The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0118-2017·Announced 2016-11-09

Actavis Recalls Ramipril Capsules Due to Incorrect Expiration Date Labeling

Actavis is recalling 15,984 bottles of Ramipril Capsules because they were labeled with an incorrect expiration date of 03/18 instead of 09/17.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is limited to a documentation/labeling error.

Plain-English summary

Actavis Laboratories, FL, Inc. is recalling 15,984 bottles of Ramipril Capsules, USP, 1.25 mg, 30-count bottles. The product was manufactured by Arrow Pharm (Malta) Ltd. and distributed by Actavis Pharma, Inc. The recall is due to a labeling error where the bottles were marked with an incorrect expiration date of 03/18 rather than the correct date of 09/17.

The affected product is identified by Lot # 1136091A and NDC 16252-570-30. The recall covers distribution nationwide and in Puerto Rico. The FDA has classified this as a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.

Consumers who have this product should check the expiration date and lot number on their bottles. If the product matches the recalled lot, they should contact their pharmacist or healthcare provider for guidance on disposal or replacement.

The recalled product

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.
Manufacturer
Actavis Laboratories, FL, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
15,984

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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