Acyclovir Tablet
FDA Recall NDC 31722-778
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 Acyclovir (NDC 31722-778). A significant event, classified as Class III, was initiated on Apr 27, 2017 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Presence of Foreign Substance: human hair melded into tablet."
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: human hair melded into tablet.
Apr 27, 2017
Jun 14, 2017
13,692 bottles
Recall Profile & Regulatory Data
Event ID
77122
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Hetero USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 13, 2017
Product Description
Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01
Batch or Lot Expiration Information
Lot# ACY16075 Exp. 09/2018
Affected Packages Involved in this Recall
31722-777-01Product
31722-777-05Product
31722-778-01Product
31722-778-05Product
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.
