Simvastatin Tablet, Film Coated
FDA Recall NDC 31722-511
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 Simvastatin (NDC 31722-511). A significant event, classified as Class III, was initiated on Dec 22, 2017 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Presence of foreign substance: metallic razor blade was found in one bottle."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Presence of foreign substance: metallic razor blade was found in one bottle.
Dec 22, 2017
Jan 24, 2018
N/A
Recall Profile & Regulatory Data
Event ID
78821
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Hetero Labs, Ltd. - Unit III
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. nationwide
Termination Date
Mar 23, 2018
Product Description
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
Batch or Lot Expiration Information
Lot# : E171280, Exp 06/19
Affected Packages Involved in this Recall
31722-510-30Product
31722-510-01Product
31722-510-10Product
31722-510-90Product
31722-511-30Product
31722-511-01Product
31722-511-10Product
31722-511-90Product
31722-512-30Product
31722-512-01Product
31722-512-10Product
31722-512-90Product
31722-513-30Product
31722-513-01Product
31722-513-10Product
31722-513-90Product
31722-514-30Product
31722-514-01Product
31722-514-05Product
31722-514-90Product
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.
