Recalls / Class II
Class IID-0161-2018
Product
Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Affected lot / code info
- Lots: 03092017@21 BUD: 3/9/2018; 03292017@33 BUD: 3/24/2018; 05092017@38 BUD: 5/4/2018; 05162017@31 BUD: 5/11/2018; 05182017@25 BUD: 5/13/2018; 07032017@40 BUD: 6/28/2018; 07142017@34 BUD: 7/9/2018; 07192017@32 BUD: 7/14/2018; 08282017@25 BUD: 8/23/2018; 09142017@8BUD: 9/9/2018; 09212017@23 BUD: 9/16/2018; 09272017@36 BUD: 9/ 22/2018; 10162017@39 BUD: 10/11/2018; 11032017@28 BUD: 10/29/2018
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.
Recalling firm
- Firm
- KRS Global Biotechnology, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 791 Park of Commerce Blvd Ste 600, N/A, Boca Raton, Florida 33487-3633
Distribution
- Quantity
- 15,700 capsules
- Distribution pattern
- Nationwide in the USA, Bermuda, and New Zealand
Timeline
- Recall initiated
- 2017-11-16
- FDA classified
- 2018-01-08
- Posted by FDA
- 2018-01-17
- Terminated
- 2020-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0161-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.