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Recall Observatory FDA recall evidence

Drug 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

D-0069-2022

October 12, 2021

Class III

Product summary

Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Event
Event 88806
Status
Terminated
Classification
Class III
Quantity
46,584 blister packs
Official record key
drug-enforcement:D-0069-2022

Official wording

Reason: Failed Moisture Limits

Code information: AC09723, Exo, Date 11/2022

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Moisture Limits