Hetero Labs Limited (Unit V) Recalls

All product recalls associated with Hetero Labs Limited (Unit V).

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Recall Summary

Total Recalls

10

Past Year

0

Class I (Serious)

1

Most Recent

Aug 2020

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–10 of 10 recalls

Losartan Potassium Tablets (Hetero Labs) – tablet defect (2020)

Failed Tablet/Capsule Specification; complaint of bulging tablet

Class IIModerate

FDAAug 6, 2020Nationwide• Hetero Labs Limited (Unit V)

Montelukast Sodium Tablets (Hetero Labs) – tablet discoloration (2018)

Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.

Class IIModerate

FDAAug 20, 2018Nationwide• Hetero Labs Limited Unit V

Montelukast Sodium Tablets (Hetero Labs) – label mix-up (2018)

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

Class I

High

FDAAug 15, 2018Nationwide• Hetero Labs Limited Unit V

Valsartan Tablets (Hetero Labs) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 8, 2018Nationwide• Hetero Labs Limited Unit V

Valsartan Tablets (Hetero Labs) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 8, 2018Nationwide• Hetero Labs Limited Unit V

Valsartan Tablets (Hetero Labs) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 8, 2018Nationwide• Hetero Labs Limited Unit V

Valsartan Tablets (Hetero Labs) – Carcinogen Impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 8, 2018Nationwide• Hetero Labs Limited Unit V

Valacyclovir Tablets 1g (Hetero Labs) – Temperature Exposure Risk (2018)

Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

Class IIModerate

FDAFeb 13, 2018Nationwide• Hetero Labs Limited Unit V

Valganciclovir Tablets 450mg (Hetero Labs) – Temperature Exposure Risk (2018)

Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

Class IIModerate

FDAFeb 13, 2018Nationwide• Hetero Labs Limited Unit V

Famciclovir Tablets 500mg (Hetero Labs) – temperature damage (2017)

Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.

Class IIModerate

FDADec 22, 2017Nationwide• Hetero Labs Limited Unit V

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Hetero Labs Limited (Unit V) Recalls

Recall Summary

Losartan Potassium Tablets (Hetero Labs) – tablet defect (2020)

Montelukast Sodium Tablets (Hetero Labs) – tablet discoloration (2018)

Montelukast Sodium Tablets (Hetero Labs) – label mix-up (2018)

Valsartan Tablets (Hetero Labs) – Carcinogen Impurity (2018)

Valsartan Tablets (Hetero Labs) – Carcinogen Impurity (2018)

Valsartan Tablets (Hetero Labs) – Carcinogen Impurity (2018)

Valsartan Tablets (Hetero Labs) – Carcinogen Impurity (2018)

Valacyclovir Tablets 1g (Hetero Labs) – Temperature Exposure Risk (2018)

Valganciclovir Tablets 450mg (Hetero Labs) – Temperature Exposure Risk (2018)

Famciclovir Tablets 500mg (Hetero Labs) – temperature damage (2017)