D-1323-2022 Class II Terminated
FDA drug recall D-1323-2022 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on Jun 29, 2022 and is designated Class II. Reason for recall: CGMP Deviations: products were stored outside the drug label specifications. The recall status is terminated (terminated Feb 13, 2024). Affected quantity: 113 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 17, 2022
- Initiation Date
- Jun 29, 2022
- Termination Date
- Feb 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 113 bottles
Product Description
Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.
Reason for Recall
CGMP Deviations: products were stored outside the drug label specifications.
Distribution Pattern
Nationwide in the USA.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1323-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026