Recalls / Class II

Class IID-1141-2018

Product

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30

Affected lot / code info

Batch: BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024, BBX2D001, BBX2D002, BBX2D009, BBX2D010, BBX2D011, BBX2D012, BBX2D013, BBX2D014, BBX2C007

Why it was recalled

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

Recalling firm

Firm

Torrent Pharma Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

150 Allen Rd Ste 102, N/A, Basking Ridge, New Jersey 07920-3856

Distribution

Quantity

169,200 bottles

Distribution pattern

Nationwide USA

Timeline

Recall initiated

2018-08-17

FDA classified

2018-08-28

Posted by FDA

2018-09-05

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1141-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.