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
Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Lot numbers, UPCs & expiration codes
Lots: 02022017@30 BUD: 1/28/2018; 04172017@29 BUD: 4/12/2018; 05082017@39 BUD: 5/3/2018; 05222017@23 BUD: 5/17/2018; 06072017@28 BUD: 6/2/2018; 06122017@42 BUD: 6/7/2018; 06192017@24 BUD: 6/14/2018; 06292017@25 BUD: 6/24/2018; 07112017@33 BUD: 7/6/2018; 07172017@35 BUD: 7/12/2018; 07282017@26 BUD: 7/23/2018; 08012017@25 BUD: 7/27/2018; 08112017@35 BUD: 8/9/2018; 08142017@30 BUD: 8/9/2018; 08172017@31 BUD: 8/12/2018; 09202017@21 BUD: 9/15/2018; 09142017@27 BUD: 9/9/2018; 10022017@38 BUD: 3/31/2018; 10102017@37 BUD: 4/8/2018; 10172017@26 BUD: 4/15/2018; 10202017@22 BUD: 4/18/2018; 10302017@29 BUD: 4/28/2018
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-0163-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 16, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- 22,520 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KRS Global Biotechnology, Inc
Original FDA data
Every field from FDA enforcement report D-0163-2018, 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: 02022017@30 BUD: 1/28/2018; 04172017@29 BUD: 4/12/2018; 05082017@39 BUD: 5/3/2018; 05222017@23 BUD: 5/17/2018; 06072017@28 BUD: 6/2/2018; 06122017@42 BUD: 6/7/2018; 06192017@24 BUD: 6/14/2018; 06292017@25 BUD: 6/24/2018; 07112017@33 BUD: 7/6/2018; 07172017@35 BUD: 7/12/2018; 07282017@26 BUD: 7/23/2018; 08012017@25 BUD: 7/27/2018; 08112017@35 BUD: 8/9/2018; 08142017@30 BUD: 8/9/2018; 08172017@31 BUD: 8/12/2018; 09202017@21 BUD: 9/15/2018; 09142017@27 BUD: 9/9/2018; 10022017@38 BUD: 3/31/2018; 10102017@37 BUD: 4/8/2018; 10172017@26 BUD: 4/15/2018; 10202017@22 BUD: 4/18/2018; 10302017@29 BUD: 4/28/2018
- Postal code
- 33487-3633
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0163-2018
- Classification
- Class II
- Recalling firm
- KRS Global Biotechnology, Inc
- Product quantity
- 22,520 capsules
- 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
- Anastrozole SR 1 mg Capsules, 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