Valsartan Tablet, Film Coated
FDA Recall NDC 31722-747
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Valsartan (NDC 31722-747). A significant event, classified as Class II, was initiated on Aug 08, 2018 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product."
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
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Aug 08, 2018
Aug 29, 2018
394,896 bottles
Recall Profile & Regulatory Data
Event ID
80773
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Hetero Labs Limited Unit V
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908
Batch or Lot Expiration Information
Lot# All Lots with expiration dates 7/2018 to 6/2020
Affected Packages Involved in this Recall
31722-745-30Product
31722-745-90Product
31722-745-05Product
31722-745-31Product
31722-745-32Product
31722-746-30Product
31722-746-90Product
31722-746-05Product
31722-746-31Product
31722-746-32Product
31722-747-30Product
31722-747-90Product
31722-747-05Product
31722-747-31Product
31722-747-32Product
31722-748-30Product
31722-748-90Product
31722-748-05Product
31722-748-31Product
31722-748-32Product
3317227469Product
Class II Completed
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Aug 08, 2018
Aug 29, 2018
316,380 bottles
Recall Profile & Regulatory Data
Event ID
80773
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Hetero Labs Limited Unit V
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307
Batch or Lot Expiration Information
Lot# All Lots with expiration dates 7/2018 to 6/2020
Affected Packages Involved in this Recall
31722-745-30Product
31722-745-90Product
31722-745-05Product
31722-745-31Product
31722-745-32Product
31722-746-30Product
31722-746-90Product
31722-746-05Product
31722-746-31Product
31722-746-32Product
31722-747-30Product
31722-747-90Product
31722-747-05Product
31722-747-31Product
31722-747-32Product
31722-748-30Product
31722-748-90Product
31722-748-05Product
31722-748-31Product
31722-748-32Product
3317227453Product
Class II Completed
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Aug 08, 2018
Aug 29, 2018
441,408 bottles
Recall Profile & Regulatory Data
Event ID
80773
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Hetero Labs Limited Unit V
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902
Batch or Lot Expiration Information
Lot# All Lots with expiration dates 7/2018 to 6/2020
Affected Packages Involved in this Recall
31722-745-30Product
31722-745-90Product
31722-745-05Product
31722-745-31Product
31722-745-32Product
31722-746-30Product
31722-746-90Product
31722-746-05Product
31722-746-31Product
31722-746-32Product
31722-747-30Product
31722-747-90Product
31722-747-05Product
31722-747-31Product
31722-747-32Product
31722-748-30Product
31722-748-90Product
31722-748-05Product
31722-748-31Product
31722-748-32Product
3317227489Product
Class II Completed
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Aug 08, 2018
Aug 29, 2018
441,408 bottles
Recall Profile & Regulatory Data
Event ID
80773
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Hetero Labs Limited Unit V
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905
Batch or Lot Expiration Information
Lot# All Lots with expiration dates 7/2018 to 6/2020
Affected Packages Involved in this Recall
31722-745-30Product
31722-745-90Product
31722-745-05Product
31722-745-31Product
31722-745-32Product
31722-746-30Product
31722-746-90Product
31722-746-05Product
31722-746-31Product
31722-746-32Product
31722-747-30Product
31722-747-90Product
31722-747-05Product
31722-747-31Product
31722-747-32Product
31722-748-30Product
31722-748-90Product
31722-748-05Product
31722-748-31Product
31722-748-32Product
3317227479Product
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.
