Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Product description
Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Lot numbers, UPCs & expiration codes
Lot: 06132017@22 BUD: 12/10/2017
Where it was sold
Nationwide in the USA, Bermuda, and New Zealand
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-0173-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 16, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- 2,239 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KRS Global Biotechnology, Inc
Original FDA data
Every field from FDA enforcement report D-0173-2018, exactly as published.
Show all FDA fields
- City
- Boca Raton
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 78553
- Address
- 791 Park of Commerce Blvd Ste 600
- Code information
- Lot: 06132017@22 BUD: 12/10/2017
- Postal code
- 33487-3633
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0173-2018
- Classification
- Class II
- Recalling firm
- KRS Global Biotechnology, Inc
- Product quantity
- 2,239 tablets
- Termination date
- May 11, 2020
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Distribution pattern
- Nationwide in the USA, Bermuda, and New Zealand
- Recall initiation date
- Nov 16, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2018