Reported Jun 15, 2016 · Terminated

CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC.,…

Aidarex Pharmaceuticals LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aidarex Pharmaceuticals LLC · 595 N Smith Ave Ste B · Corona, CA · 92880-6920

- CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE
- Packaged in 473 ML Bottles
- Rx Only
MFGHI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701
Packaged ByAidarex PHARMACEUTICALS
NDC33261-0447-01

Lot codes and dates: 12 of 12 products
Products covered by this recall
# Product as published
1 45335-1, Expiry: 2017/02
2 Lot #: 46807-1, Expiry: 2017/01
3 Lot #: 44359-1, Expiry: 2017/02
4 Lot #: 44395-1, Expiry: 2017/02
5 Lot #: 44693-1, Expiry: 2017/02
6 Lot #: 44694-1, Expiry: 2017/02
7 Lot #: 43707-1, Expiry: 2017/03
8 Lot #: 47697-1, Expiry: 2017/03
9 Lot #: 48605-1, Expiry: 2017/03
10 Lot #: 48659-1, Expiry: 2017/03
11 Lot #: 47772-1, Expiry: 2017/05
12 Lot #: 48271-1, Expiry: 2017/05.
Amount recalled: 292 Bottles

The agency filed one notice per product. You are reading one of them; the other one is below.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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