Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
Reported: June 1, 2016 Initiated: March 23, 2016 #D-0875-2016
Product Description
Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
Reason for Recall
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 3,112,657 mL
- Distribution
- Nationwide and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16. Recalled by Akorn, Inc.. Units affected: 3,112,657 mL.
Why was this product recalled? ▼
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 1, 2016. Severity: Moderate. Recall number: D-0875-2016.
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