Drug 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.
D-0611-2018
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 79635
- Status
- Terminated
- Classification
- Class III
- Quantity
- 56,1800 unit dose cups
- Official record key
drug-enforcement:D-0611-2018
Official wording
Reason: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Code information: Lot #: 350836, Exp 05/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent