D-0515-2022 Class II Terminated
FDA drug recall D-0515-2022 was initiated by Ultra Seal Corporation on Jan 24, 2022 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated Oct 16, 2023). Affected quantity: 1,474,050 packets.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 9, 2022
- Initiation Date
- Jan 24, 2022
- Termination Date
- Oct 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,474,050 packets
Product Description
ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: AK9797, AK9254
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0515-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026