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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0989-2022 |
| Event ID | 90297 |
| Brand | EAR CARE EARACHE DROPS |
| Generic Name | ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFUR |
| Manufacturer | ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFUR |
| Original Package? | 1 |
| Active Substance | ANEMONE PULSATILLA ATROPA BELLADONNA |
| Drug Route | AURICULAR (OTIC) |
| Distribution | Nationwide within the USA |
| Quantity | 16,374 bottles |
| Recall Reason | Microbial contamination of non-sterile product. |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 11822-3644 |
| Drug UPC | 0011822364430 |
| 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 | I76KB35JEV 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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