CLASS II Drug recall · Reported 17 Jan 2018 · FDA Enforcement Report
Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin recalled
KRS Global Biotechnology is recalling Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder, distributed nationwide in the US. The recall was initiated on 16 Nov 2017 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes Lots: 07282017@24 BUD: 1/24/2018; 08162017@33 BUD: 2/12/2018
Quantity recalled 100 jars
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Recall number D-0171-2018
FDA event ID 78553
Classification Class II
Status Terminated
Recall initiated 16 Nov 2017
FDA classified 8 Jan 2018
Reported 17 Jan 2018
Type Voluntary: Firm initiated
Customers notified by Letter
Timeline
16 Nov 2017 Recall initiated by company 8 Jan 2018 Classified by FDA +53 days 17 Jan 2018 Published in enforcement report +9 days
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Where it was distributed
Nationwide in the USA, Bermuda, and New Zealand
Nationwide
Questions about this recall
Why was it 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.
Which lots are affected? Lots: 07282017@24 BUD: 1/24/2018; 08162017@33 BUD: 2/12/2018
Where was it sold? Nationwide in the USA, Bermuda, and New Zealand
What should I do if I have it? Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean? Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event 46 other products · FDA event 78553 This product is part of a recall event; the main page for the event is Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized recalled .
Reported Class Recall Company Reason Where 17 Jan 2018 CLASS II Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream recalled KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II Savinase 100 mcg/mL Topical Solution in a Droptainer recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Progesterone 3% Topical Cream recalled by KRS Global Biotechnology KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II Quadmix #18 Vial recalled by KRS Global Biotechnology KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Human Chorionic Gonadotropin, Vial-Lyophilized, For SC Use recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment recalled KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II Bi-Est (Estriol/Estradiol) (80/20) + Progesterone recalled KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream recalled KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Vitamin 9 A/B Lyophilized Vial, For IM Use recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Liothyronine SR (T3) recalled by KRS Global Biotechnology KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Quadmix #17 Vial recalled by KRS Global Biotechnology KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only Vial recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream recalled KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II Nicotinamide Adenine Dinucleotide 500 mg recalled KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II Vitamin 9 Lyophilized Vial, For IM Use recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder recalled KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Estriol 0.1% (1 mg/gm) Cream recalled by KRS Global Biotechnology KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II Oxytocin in 0.9% Sodium Chloride Solution (PF) IV recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Sincalide 5 mcg Lyophilized Vials, For IV Use recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone recalled KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Vitamin 10 B Lyophilized Vial, For IM Use recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II 7-Keto DHEA 25mg Capsule recalled by KRS Global Biotechnology KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Human Chorionic Gonadotropin (ODT) recalled by KRS Global Biotechnology KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Sermorelin (ODT) recalled by KRS Global Biotechnology KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream recalled KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder recalled KRS Global Biotechnology Packaging Defects Nationwide 17 Jan 2018 CLASS II Quadmix #16 Vial recalled by KRS Global Biotechnology KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II 7-Ketodehydroepiandrosterone (7-Keto DHEA) recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Anastrozole SR recalled by KRS Global Biotechnology KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Hydroxocobalamin 1 mg/mL Vial For IM Use recalled KRS Global Biotechnology Other Nationwide 17 Jan 2018 CLASS II Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial recalled KRS Global Biotechnology Other Nationwide
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