Acarbose Tablet
FDA Recall NDC 0054-0141
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Acarbose (NDC 0054-0141). A significant event, classified as Class II, was initiated on Apr 02, 2015 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Apr 02, 2015
Jun 03, 2015
a) 575 Blister Packs, b) 12,802 Bottles
Recall Profile & Regulatory Data
Event ID
70990
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Boehringer Ingelheim Roxane Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 19, 2016
Product Description
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25
Batch or Lot Expiration Information
Lot# a)
Lot# 460073A Exp 04/2016 b)
Lot# 460073B Exp 04/2016
Affected Packages Involved in this Recall
0054-0140-25Product
0054-0141-20Product
0054-0141-25Product
0054-0142-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
