Why it was recalled
Labeling: Product Contains Undeclared API; Incorrect formulation
Product description
Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1.
Lot numbers, UPCs & expiration codes
Lot #s: Z60852, Z60012
Where it was sold
UT
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-0099-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 17, 2020
- FDA report date
- Nov 25, 2020
- Quantity
- 399 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Grato Holdings, Inc.
Original FDA data
Every field from FDA enforcement report D-0099-2021, exactly as published.
Show all FDA fields
- City
- Woodbine
- State
- IA
- Status
- Terminated
- Country
- United States
- Event ID
- 86690
- Address
- 201 Apple Blvd
- Code information
- Lot #s: Z60852, Z60012
- Postal code
- 51579-1503
- Report date
- Nov 25, 2020
- Product type
- Drugs
- Recall number
- D-0099-2021
- Classification
- Class III
- Recalling firm
- Grato Holdings, Inc.
- Product quantity
- 399 bottles
- Termination date
- Oct 18, 2022
- Reason for recall
- Labeling: Product Contains Undeclared API; Incorrect formulation
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1.
- Distribution pattern
- UT
- Recall initiation date
- Sep 17, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 19, 2020