Sorbugen Syrup
FDA Recall NDC 52083-660
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 Sorbugen (NDC 52083-660). A significant event, classified as Class II, was initiated on Jun 21, 2019 by Kramer Novis. The reported reason for this action was: "CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations."
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 II Terminated
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Jun 21, 2019
Jul 31, 2019
7392 bottles
Recall Profile & Regulatory Data
Event ID
83190
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pharma-Natural Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Termination Date
Oct 27, 2021
Product Description
SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-660-16.
Batch or Lot Expiration Information
Lot# All lots remaining within expiry.
Affected Packages Involved in this Recall
52083-660-16Product
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.
