Recall Enforment Report D-1114-2018

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Hetero Labs Limited Unit V, originally initiated on 08-08-2018 for the product 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 The product was recalled due to cgmp deviations: carcinogen impurity detected in api used to manufacture drug product.. The product was distributed nationwide and the recall is currently completed.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-1114-2018	08-08-2018	08-29-2018	Class II	394,896 bottles	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	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Completed
D-1113-2018	08-08-2018	08-29-2018	Class II	316,380 bottles	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	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Completed
D-1115-2018	08-08-2018	08-29-2018	Class II	441,408 bottles	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	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Completed
D-1116-2018	08-08-2018	08-29-2018	Class II	441,408 bottles	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	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Completed

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
31722-745	Valsartan	Valsartan	Tablet, Film Coated	Oral	Camber Pharmaceuticals, Inc.	Human Prescription Drug
31722-746	Valsartan	Valsartan	Tablet, Film Coated	Oral	Camber Pharmaceuticals, Inc.	Human Prescription Drug
31722-747	Valsartan	Valsartan	Tablet, Film Coated	Oral	Camber Pharmaceuticals, Inc.	Human Prescription Drug
31722-748	Valsartan	Valsartan	Tablet, Film Coated	Oral	Camber Pharmaceuticals, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	80773 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1114-2018 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	394,896 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-29-2018
Recall Initiation Date	08-08-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Hetero Labs Limited Unit V
Code Info	All Lots with expiration dates 7/2018 to 6/2020 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227469
Status	Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.

Field Name	Field Value
Event ID	80773 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1113-2018 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	316,380 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-29-2018
Recall Initiation Date	08-08-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Hetero Labs Limited Unit V
Code Info	All Lots with expiration dates 7/2018 to 6/2020 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227453
Status	Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.

Field Name	Field Value
Event ID	80773 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1115-2018 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	441,408 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-29-2018
Recall Initiation Date	08-08-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Hetero Labs Limited Unit V
Code Info	All Lots with expiration dates 7/2018 to 6/2020 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227479
Status	Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.

Field Name	Field Value
Event ID	80773 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1116-2018 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	441,408 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-29-2018
Recall Initiation Date	08-08-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Hetero Labs Limited Unit V
Code Info	All Lots with expiration dates 7/2018 to 6/2020 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227489
Status	Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.