Product Safety Recalls

Product Recall Tracker

ANEMONE PULSATILLA Recall D-0989-2022

Description: 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

ANEMONE PULSATILLA Recall D-0989-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0989-2022
Event ID90297
BrandEAR CARE EARACHE DROPS
Generic NameATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFUR
ManufacturerATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFUR
Original Package?1
Active SubstanceANEMONE PULSATILLA ATROPA BELLADONNA
Drug RouteAURICULAR (OTIC)
DistributionNationwide within the USA
Quantity16,374 bottles
Recall ReasonMicrobial contamination of non-sterile product.
Drug ClassificationClass II
Drug Code Info20220615
Product NDC11822-3644
Drug UPC0011822364430
Recall Initiation Date20220524
Report Date20220615
Classification Date20220608
Address201 Apple Blvd
Woodbine, IA 51579-1503
United States
Recalling FirmGrato Holdings, Inc.
Initial Notification Letter
Unique Ingredient IdentifierI76KB35JEV WQZ3G9PF0H
Structured Product Labeling (SPL ID)678c8e7e-1d5b-f12a-e053-2991aa0ab6cc
Structured Product Labeling (SPL Set ID)58f1f79f-f1dd-3094-e053-2991aa0ac591
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