Multi-event July 2018 FDA Recall Drug by Teva Pharmaceuticals Usa
This Multi-event Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on July 16, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed throughout the United States, including Hawaii and Puerto Rico and the recall is currently ongoing.
Reported Recall Events
D-0988-2018 D-0986-2018 D-0987-2018 D-0989-2018 D-0982-2018 D-0984-2018 D-0985-2018 D-0983-2018 D-0981-2018
Recall Number: D-0988-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-16-2018
08-01-2018
15,347 90-count bottles, 8,378 1000-count bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
Batch or Lot Expiration Information
Lot# NDC 0591-2169-19 Lot Numbers: 1177880A, 1220831A, 1263941A NDC 0591-2169-10 1175922M, 1220826M, 1236294M, 1240427M, 1270616A
Recall Number: D-0986-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-16-2018
08-01-2018
8,046 30-count bottles, 20,841 90-count bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
Batch or Lot Expiration Information
Lot# Lot Numbers: NDC 0591-2167-30 1196936A, 1238463A, 1270617A NDC 0591-2167-19 1196934M, 1238462M, 1268429A
Recall Number: D-0987-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-16-2018
08-01-2018
30,793 90-count bottles, 1,158 1000-count bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
Batch or Lot Expiration Information
Lot# Lot Numbers: NDC 0591-2168-19 1175947M, 1175948M, 1177115A, 1219361A, 1240434M, 1250704M NDC 0591-2168-10 1177114A, 1219360M, 1250706A
Recall Number: D-0989-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-16-2018
08-01-2018
13,555 90-count bottles; 2,892 500-count bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
Batch or Lot Expiration Information
Lot# NDC 0591-2170-19 Lot Numbers: 1208002A, 1247282M, 1263944M NDC 0591-2170-05 Lot Numbers: 1208000M, 1208001M, 1240425A
Recall Number: D-0982-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-16-2018
08-01-2018
195,234 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2316-19.
Batch or Lot Expiration Information
Lot# Lot Numbers: 1191160M, 1191161M, 1191162A, 1219363M, 1219364M, 1219365A, 1225613A, 1233944M, 1233945M, 1253253M, 1253254M
Recall Number: D-0984-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-16-2018
08-01-2018
64,168 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19
Batch or Lot Expiration Information
Lot# Lot Numbers: 1191185M, 1191186M, 1225615M, 1233948M, 1250718M, 1253257M
Recall Number: D-0985-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-16-2018
08-01-2018
164,922 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19.
Batch or Lot Expiration Information
Lot# Lot Numbers: 1191188M, 1191189M, 1191190M, 1199220M, 1217576M, 1217577M, 1217578M, 1220832M, 1220833M, 1247283M, 1247284M, 1247285M, 1247286M, 1247287A, 1280632M, 1280633M
Recall Number: D-0983-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-16-2018
08-01-2018
99,554 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2317-19.
Batch or Lot Expiration Information
Lot# Lot Numbers: 1191164M, 1191165M, 1191166M, 1191167A, 1225612M, 1250717M, 1256111M, 1288798M
Recall Number: D-0981-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-16-2018
08-01-2018
56,603 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19.
Batch or Lot Expiration Information
Lot# 1191191M, 1191192M, 1191193M, 1191194M, 1191195M, 1238466M, 1238467M, 1253261M 1256125M, 1277709M
