Drug 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.
D-0975-2016
Product summary
- Event
- Event 74315
- Status
- Terminated
- Classification
- Class II
- Quantity
- 292 Bottles
- Official record key
drug-enforcement:D-0975-2016
Official wording
Reason: Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
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.
Distribution pattern: U.S. including: CA, ND, PA, TN
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications