FDA recall D-0118-2017

Actavis Laboratories, FL, Inc. · Class III · 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.

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status
Ongoing
Initiation date
2016-08-30
Report date
2016-11-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0118-2017