Recalls / Class III
Class IIID-0321-2021
Product
Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42
- Affected lot / code info
- Lot # 27479, exp. date 11/2022
Why it was recalled
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Recalling firm
- Firm
- Washington Homeopathic Products, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 260 J R Hawvermale Way, N/A, Berkeley Springs, West Virginia 25411-6957
Distribution
- Quantity
- 1,909 bottles
- Distribution pattern
- Product was distributed to MD, CO & TX only
Timeline
- Recall initiated
- 2021-03-18
- FDA classified
- 2021-04-05
- Posted by FDA
- 2021-04-14
- Terminated
- 2021-05-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0321-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.