FDA Drug Recalls

Recalls / Class II

Class IID-0515-2022

Product

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

Affected lot / code info
Lot #: AK9797, AK9254

Why it was recalled

cGMP deviations

Recalling firm

Firm
Ultra Seal Corporation
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
521 Main St, N/A, New Paltz, New York 12561-1609

Distribution

Quantity
1,474,050 packets
Distribution pattern
Nationwide within the United States

Timeline

Recall initiated
2022-01-24
FDA classified
2022-01-31
Posted by FDA
2022-02-09
Terminated
2023-10-16
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0515-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls