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.
Reported: April 4, 2018 Initiated: March 29, 2018 #D-0611-2018
Product Description
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.
Reason for Recall
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 56,1800 unit dose cups
- Distribution
- Nationwide in the USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Akorn, Inc.. Units affected: 56,1800 unit dose cups.
Why was this product recalled? ▼
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 4, 2018. Severity: Low. Recall number: D-0611-2018.
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