Product Safety Recalls

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ANEMONE PATENS WHOLE Recall D-0991-2022

Description: Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15

ANEMONE PATENS WHOLE Recall D-0991-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0991-2022
Event ID90297
BrandWALGREENS EARACHE DROPS
Generic NameBELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR
ManufacturerBELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR
Original Package?1
Active SubstanceANEMONE PATENS WHOLE BELLADONNA LEAF
Drug RouteAURICULAR (OTIC)
DistributionNationwide within the USA
Quantity31,872 bottles
Recall ReasonMicrobial contamination of non-sterile product.
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0363-3233
Drug UPC0311917217123
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 Identifier4M1169RWJD 6GZW20TIOI
Structured Product Labeling (SPL ID)c573cf1a-dd63-e950-e053-2995a90a58f3
Structured Product Labeling (SPL Set ID)c573dc3c-992e-604d-e053-2995a90a0ff4
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