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 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Lot numbers, UPCs & expiration codes
Lots: 06082017@33 BUD: 12/5/2017; 06152017@4 BUD: 12/12/2017; 07272017@4 BUD: 1/23/2018; 10042017@22 BUD: 4/2/2018; 09282017@3 BUD: 3/27/2018
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-0178-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 16, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- 2,274 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KRS Global Biotechnology, Inc
Original FDA data
Every field from FDA enforcement report D-0178-2018, 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
- Lots: 06082017@33 BUD: 12/5/2017; 06152017@4 BUD: 12/12/2017; 07272017@4 BUD: 1/23/2018; 10042017@22 BUD: 4/2/2018; 09282017@3 BUD: 3/27/2018
- Postal code
- 33487-3633
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0178-2018
- Classification
- Class II
- Recalling firm
- KRS Global Biotechnology, Inc
- Product quantity
- 2,274 vials
- 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 20,000 iu/Vial, Lyophilized - For SC Use, 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