Recalls / Class II
Class IID-0193-2018
Product
Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Affected lot / code info
- Lot: 07112017@32 BUD: 1/7/2018
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
- 3,000 tablets
- 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-0193-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.