Recalls / Class II

Class IID-0232-2016

Product

HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.

Affected lot / code info

T084M14A, T085M14A, T086M14A; Exp 12/16

Why it was recalled

Presence of Particulate Matter.

Recalling firm

Firm

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

150 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216

Distribution

Quantity

912 HDPE bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2015-10-07

FDA classified

2015-11-13

Posted by FDA

2015-11-25

Terminated

2016-11-16

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0232-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.