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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0991-2022 |
| Event ID | 90297 |
| Brand | WALGREENS EARACHE DROPS |
| Generic Name | BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR |
| Manufacturer | BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR |
| Original Package? | 1 |
| Active Substance | ANEMONE PATENS WHOLE BELLADONNA LEAF |
| Drug Route | AURICULAR (OTIC) |
| Distribution | Nationwide within the USA |
| Quantity | 31,872 bottles |
| Recall Reason | Microbial contamination of non-sterile product. |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0363-3233 |
| Drug UPC | 0311917217123 |
| Recall Initiation Date | 20220524 |
| Report Date | 20220615 |
| Classification Date | 20220608 |
| Address | 201 Apple Blvd Woodbine, IA 51579-1503 United States |
| Recalling Firm | Grato Holdings, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4M1169RWJD 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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