Chlorhexidine Gluconate Oral Rinse recall: Subpotent
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
Why was Chlorhexidine Gluconate Oral Rinse 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?
Lot #: 350836, Exp 05/18
- Product
- Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
- Recalling firm
- Akorn, Inc.
- Quantity
- 56,1800 unit dose cups
- Distribution
- Nationwide in the USA
- Recall date
- April 4, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)