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Recall Observatory FDA recall evidence

Drug product

Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3

D-0989-2022

May 24, 2022

Class II

Product summary

Firm
Grato Holdings, Inc.
Event
Event 90297
Status
Terminated
Classification
Class II
Quantity
16,374 bottles
Official record key
drug-enforcement:D-0989-2022

Official wording

Reason: Microbial contamination of non-sterile product.

Code information: Lot #: G11639, Exp. Date 09/24

Distribution pattern: Nationwide within the USA

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination