24-HOUR Oral Care q4 Kit with Ballard* Technology recall: Subpotent
24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL…
Why was 24-HOUR Oral Care q4 Kit with Ballard* Technology recalled?
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202522468, 0202522470, Exp 03/18; 0202518966, 0202522469, 0202522471, 0202533449, 0202533456, 0202533463, 0202543351, 0202548200, Exp 04/18
- Product
- 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL…
- Recalling firm
- Akorn, Inc.
- Quantity
- 20,587 unit dose cups
- Distribution
- Nationwide in the USA
- Recall date
- April 4, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)