AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count bliste... — FDA record D-0069-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 12, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15
Reason
Failed Moisture Limits
Classification
Class III
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Quantity
46,584 blister packs
Agency-reported status
Terminated
Source record identifier
D-0069-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityAC09723, Exo, Date 11/2022

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide within the United States

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Nov 3, 2021
Recall initiation date
Oct 12, 2021
Center classification date
Oct 26, 2021
Termination date
Aug 31, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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