Recalls / Class II

Class IID-0975-2016

Product

CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.

Affected lot / code info

Lot #: 45335-1, Expiry: 2017/02; Lot #: 46807-1, Expiry: 2017/01; Lot #: 44359-1, Expiry: 2017/02; Lot #: 44395-1, Expiry: 2017/02; Lot #: 44693-1, Expiry: 2017/02; Lot #: 44694-1, Expiry: 2017/02; Lot #: 43707-1, Expiry: 2017/03; Lot #: 47697-1, Expiry: 2017/03; Lot #: 48605-1, Expiry: 2017/03; Lot #: 48659-1, Expiry: 2017/03; Lot #: 47772-1, Expiry: 2017/05; Lot #: 48271-1, Expiry: 2017/05.

Why it was recalled

Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.

Recalling firm

Firm

Aidarex Pharmaceuticals LLC

Notification channel

FAX

Type

Voluntary: Firm initiated

Address

595 N Smith Ave Ste B, N/A, Corona, California 92880-6920

Distribution

Quantity

292 Bottles

Distribution pattern

U.S. including: CA, ND, PA, TN

Timeline

Recall initiated

2016-06-01

FDA classified

2016-06-08

Posted by FDA

2016-06-15

Terminated

2016-10-14

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0975-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.