D-0975-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2016
- Initiation Date
- June 1, 2016
- Termination Date
- October 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 292 Bottles
Product Description
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.
Reason for Recall
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Distribution Pattern
U.S. including: CA, ND, PA, TN
Code Information
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.