Home / Recalls / KRS Global Biotechnology, Inc / D-0193-2018

D-0193-2018 Class II Terminated

Recalled by KRS Global Biotechnology, Inc — Boca Raton, FL

FDA drug recall D-0193-2018 was initiated by KRS Global Biotechnology, Inc on November 16, 2017 and is designated Class II. 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. The recall status is terminated (terminated May 11, 2020). Affected quantity: 3,000 tablets.

Recall Details

Product Type
Drugs
Report Date
January 17, 2018
Initiation Date
November 16, 2017
Termination Date
May 11, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,000 tablets

Product Description

Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

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.

Distribution Pattern

Nationwide in the USA, Bermuda, and New Zealand

Code Information

Lot: 07112017@32 BUD: 1/7/2018

Other recalls by KRS Global Biotechnology, Inc

  • D-0071-2020 Class II — LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (P (September 12, 2019)
  • D-0110-2020 Class II — Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 7 (September 12, 2019)
  • D-0118-2020 Class II — Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single (September 12, 2019)
  • D-0090-2020 Class II — Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS G (September 12, 2019)
  • D-0039-2020 Class II — Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use (September 12, 2019)
  • D-0043-2020 Class II — Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, R (September 12, 2019)
  • D-0114-2020 Class II — Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 (September 12, 2019)
  • D-0069-2020 Class II — LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syr (September 12, 2019)
  • D-0072-2020 Class II — Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine H (September 12, 2019)
  • D-0053-2020 Class II — Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL (September 12, 2019)

FDA data resources