Why it was recalled
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
U.S. including: CA, ND, PA, TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0975-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 1, 2016
- FDA report date
- Jun 15, 2016
- Quantity
- 292 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidarex Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-0975-2016, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 74315
- Address
- 595 N Smith Ave Ste B
- 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.
- Postal code
- 92880-6920
- Report date
- Jun 15, 2016
- Product type
- Drugs
- Recall number
- D-0975-2016
- Classification
- Class II
- Recalling firm
- Aidarex Pharmaceuticals LLC
- Product quantity
- 292 Bottles
- Termination date
- Oct 14, 2016
- Reason for recall
- Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S. including: CA, ND, PA, TN
- Recall initiation date
- Jun 1, 2016
- Initial firm notification
- FAX
- Center classification date
- Jun 8, 2016