Class III
Terminated
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.
This recall has been terminated (originally issued April 4, 2018).
- Company
- Akorn, Inc.
- Recall Initiated
- March 29, 2018
- Posted
- April 4, 2018
- Recall Number
- D-0611-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 56,1800 unit dose cups
- Firm Location
- Lake Forest, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: 350836, Exp 05/18
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