Product Safety Recalls

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ATROPA BELLADONNA Recall D-1165-2022

Description: SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012 NDC 61152-199-99, UPC 69682 29101

ATROPA BELLADONNA Recall D-1165-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1165-2022
Event ID90384
BrandSNORESTOP NASOSPRAY 60
Generic NameSTRYCHNOS NUX-VOMICA SEED,ATROPA BELLADONNA,EPHEDRA DISTACHYA FLOWERING TWIG,GOLDENSEAL,POTASSIUM DICHROMATE,TEUCRIUM MARUM,HISTAMINE DIHYDROCHLORIDE LIQUID
ManufacturerSTRYCHNOS NUX-VOMICA SEED,ATROPA BELLADONNA,EPHEDRA DISTACHYA FLOWERING TWIG,GOLDENSEAL,POTASSIUM DICHROMATE,TEUCRIUM MARUM,HISTAMINE DIHYDROCHLORIDE LIQUID
Original Package?1
Active SubstanceATROPA BELLADONNA EPHEDRA DISTACHYA FLOWERING TWIG
Drug RouteNASAL
DistributionNationwide within the United States
Quantity1074 units
Recall ReasonMicrobial Contamination of Non-Sterile Product. Microbial contamination identified as Providencia rettgeri.
Drug ClassificationClass I
Drug Code Info20220706
Product NDC61152-199
Product NUIN0000185375 N0000175629 N0000184306
Pharma Class (PE)Increased Histamine Release [PE]
Pharma Class (EPC)Non-Standardized Plant Allergenic Extract [EPC]
Pharma Class (CS)Allergens [CS]
Recall Initiation Date20220609
Report Date20220706
Classification Date20220627
Address591 Constitution Ave Ste A
Camarillo, CA 93012-9106
United States
Recalling FirmGreen Pharmaceuticals, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Unique Ingredient IdentifierWQZ3G9PF0H R55VQ87DP3
Structured Product Labeling (SPL ID)7d67d154-e4a6-3bec-e053-2a91aa0ad320
Structured Product Labeling (SPL Set ID)f4d26053-32aa-4cc9-8460-556acc38fe33
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