Why it was recalled
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Product description
Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42
Lot numbers, UPCs & expiration codes
Lot # 27479, exp. date 11/2022
Where it was sold
Product was distributed to MD, CO & TX only
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0321-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 18, 2021
- FDA report date
- Apr 14, 2021
- Quantity
- 1,909 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Washington Homeopathic Products, Inc.
Original FDA data
Every field from FDA enforcement report D-0321-2021, exactly as published.
Show all FDA fields
- City
- Berkeley Springs
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 87547
- Address
- 260 J R Hawvermale Way
- Code information
- Lot # 27479, exp. date 11/2022
- Postal code
- 25411-6957
- Report date
- Apr 14, 2021
- Product type
- Drugs
- Recall number
- D-0321-2021
- Classification
- Class III
- Recalling firm
- Washington Homeopathic Products, Inc.
- Product quantity
- 1,909 bottles
- Termination date
- May 13, 2021
- Reason for recall
- An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42
- Distribution pattern
- Product was distributed to MD, CO & TX only
- Recall initiation date
- Mar 18, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 5, 2021