Class III
Terminated
Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
This recall has been terminated (originally issued August 23, 2017).
- Company
- Akorn, Inc.
- Recall Initiated
- July 12, 2017
- Posted
- August 23, 2017
- Recall Number
- D-1089-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 40,978 unit dose cups
- Firm Location
- Lake Forest, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Crystallization with subpotent out of specification assay results for chlorhexidine.
Distribution
Nationwide in the USA
Lot / Code Info
Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434, EXP 07-2018.
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