Recalls / Class II
Class IID-0991-2022
Product
Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15
- Brand name
- Walgreens Earache Drops
- Generic name
- Belladonna Leaf, Calcium Carbonate, Chamomile, Lycopodium Clavatum Spore, Anemone Patens, And Sulfur
- Active ingredients
- Anemone Patens Whole, Belladonna Leaf, Calcium Carbonate, Chamomile, Lycopodium Clavatum Spore, Sulfur
- Route
- Auricular (otic)
- NDC
- 0363-3233
- Affected lot / code info
- Lot #: G11639, Exp. Date 09/24
Why it was recalled
Microbial contamination of non-sterile product.
Recalling firm
- Firm
- Grato Holdings, Inc.
- Manufacturer
- Walgreen Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 201 Apple Blvd, Woodbine, Iowa 51579-1503
Distribution
- Quantity
- 31,872 bottles
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2022-05-24
- FDA classified
- 2022-06-08
- Posted by FDA
- 2022-06-15
- Terminated
- 2023-06-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0991-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.