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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1165-2022 |
| Event ID | 90384 |
| Brand | SNORESTOP NASOSPRAY 60 |
| Generic Name | STRYCHNOS NUX-VOMICA SEED,ATROPA BELLADONNA,EPHEDRA DISTACHYA FLOWERING TWIG,GOLDENSEAL,POTASSIUM DICHROMATE,TEUCRIUM MARUM,HISTAMINE DIHYDROCHLORIDE LIQUID |
| Manufacturer | STRYCHNOS NUX-VOMICA SEED,ATROPA BELLADONNA,EPHEDRA DISTACHYA FLOWERING TWIG,GOLDENSEAL,POTASSIUM DICHROMATE,TEUCRIUM MARUM,HISTAMINE DIHYDROCHLORIDE LIQUID |
| Original Package? | 1 |
| Active Substance | ATROPA BELLADONNA EPHEDRA DISTACHYA FLOWERING TWIG |
| Drug Route | NASAL |
| Distribution | Nationwide within the United States |
| Quantity | 1074 units |
| Recall Reason | Microbial Contamination of Non-Sterile Product. Microbial contamination identified as Providencia rettgeri. |
| Drug Classification | Class I |
| Drug Code Info | 20220706 |
| Product NDC | 61152-199 |
| Product NUI | N0000185375 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 Date | 20220609 |
| Report Date | 20220706 |
| Classification Date | 20220627 |
| Address | 591 Constitution Ave Ste A Camarillo, CA 93012-9106 United States |
| Recalling Firm | Green Pharmaceuticals, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | WQZ3G9PF0H 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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