Drug recall
Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015…
FDA recall event 90297 · Class II · Grato Holdings, Inc.
Key facts
| Event ID | 90297 |
|---|---|
| Recall numbers | D-0989-2022, D-0990-2022, D-0991-2022 |
| Recalling firm | Grato Holdings, Inc. |
| Product type | Drugs |
| Products | Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15, 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, Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Microbial contamination of non-sterile product. |
| Initiation date | May 24, 2022 |
| Report date | Jun 15, 2022 |
| Termination date | Jun 8, 2023 |
| City | Woodbine |
| State | IA |
| Country | United States |
| FEI number | 1931484 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: