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Dozens of Compounded Preparations Recalled


January 19, 2018

KRS Global Biotechnology Inc. is recalling nearly 3 dozen compounded prescription preparations because of labelling errors. Specifically, beyond-use dates (BUD) listed on the products exceed the BUD of 1 or more ingredients used to make the final product.

The recalls, included in the January 17, 2018, US Food and Drug Administration (FDA) Enforcement Report, were designated class II by the FDA January 8, 2018. The designation signals use of the affected products could cause temporary or reversible adverse effects. The likelihood of serious harm is remote.

The following products are included in the recall:

  • anastrozole 0.5-mg capsules from lots 03092017@21 (BUD 3/9/18), 03292017@33 (BUD 3/24/18), 05092017@38 (BUD 5/4/18), 05162017@31 (BUD 5/11/18), 05182017@25 (BUD 5/13/18), 07032017@40 (BUD 6/28/2018), 07142017@34 (BUD 7/9/18), 07192017@32 (BUD 7/14/18), 08282017@25 (BUD 8/23/18), 09142017@8 (BUD 9/9/18), 09212017@23 (BUD 9/16/18), 09272017@36 (BUD 9/22/18), 10162017@39 (BUD 10/11/18), and 11032017@28 (BUD 10/29/18);
  • amphotericin 60 mg/chloramphenicol 600 mg/hydrocortisone 10 mg otic powder packaged in jars from lot 07282017@25 (BUD 1/24/18);
  • anastrozole SR 1-mg capsules from lots 02022017@30 (BUD 1/28/18), 04172017@29 (BUD 4/12/18), 05082017@39 (BUD 5/3/18), 05222017@23 (BUD 5/17/18), 06072017@28 (BUD 6/2/18), 06122017@42 (BUD 6/7/18), 06192017@24 (BUD 6/14/18), 06292017@25 (BUD 6/24/18), 07112017@33 (BUD 7/6/18), 07172017@35 (BUD 7/12/18), 07282017@26 (BUD 7/23/18), 08012017@25 (BUD 7/27/18), 08112017@35 (BUD 8/9/18), 08142017@30 (BUD 8/9/18), 08172017@31 (BUD 8/12/2018), 09202017@21 (BUD 9/15/18), 09142017@27 (BUD 9/9/18), 10022017@38 (BUD 3/31/18), 10102017@37 (BUD 4/8/18), 10172017@26 (BUD 4/15/18), 10202017@22 (BUD 4/18/18), and 10302017@29 (BUD 4/28/18); 
  • arginine 150 mg/lysine hydrogen chloride 50 mg/glutamine 200 mg/g topical cream packaged in jars from lot 05242017@54 (BUD 11/20/17);
  • benzocaine 20%/lidocaine 6%/tetracaine 4% cream packaged in jars from lots 06072017@22 (BUD 12/4/17), 06222017@30 (BUD 12/19/17), 08032017@31 (BUD 1/30/18), 09212017@21 (BUD 3/20/18), and 10232017@20 (BUD 11/22/17);
  • benzocaine 20%/lidocaine 8%/tetracaine 4% topical cream packaged in jars from lots 07142017@31 (BUD 1/10/18), 09202017@22 (BUD 3/19/18), and 10042017@25 (BUD 4/2/18);
  • benzocaine 20%/lidocaine 8%/tetracaine 8% topical cream packaged in jars from lots 06072017@38 (BUD 12/4/17), 07062017@48 (BUD 1/2/18), 08012017@23 (BUD 1/28/18), 08212017@36 (BUD 2/17/18), and 09182017@26 (BUD 3/17/18);
  • bi-est (estriol/estradiol) (80/20) + progesterone 7.5 mg/200 mg cream packaged in jars from lot 08172017@39 (BUD 12/15/17);
  • chloramphenicol 50 mg/sulfamethoxazole 50 mg/amphotericin-B 5-mg capsules for otic use from lot 08212017@24 (BUD 2/17/18);
  • chloramphenicol 500 mg/amphotericin 50 mg otic powder packaged in jars from lot 08162017@32 (BUD 2/12/18);
  • chloramphenicol 500 mg/sulfamethoxazole 500 mg/amphotericin 50 mg otic powder packaged in jars from lots 07282017@24 (BUD 1/24/18) and 08162017@33 (BUD 2/12/18);
  • estriol 0.1% (1 mg/gm) cream packaged in jars from lot 07182017@45 (BUD 1/14/18);
  • human chorionic gonadotropin, 500 iu, orally disintegrating tablets from lot 06132017@22 (BUD 12/10/17);
  • human chorionic gonadotropin, 2500 units, lyophilized vial for subcutaneous use from lots 06212017@19 (BUD 12/18/17) and 10052017@1 (BUD 4/3/18);
  • human chorionic gonadotropin, 5000 iu, lyophilized vial for subcutaneous use from lots 06132017@2 (BUD 12/10/17), 07262017@17 (BUD 1/22/18), and 10032017@1 (BUD 4/1/18);
  • human chorionic gonadotropin, 6000 iu, lyophilized vial for subcutaneous use from lot 08302017@11 (BUD 2/26/18);
  • human chorionic gonadotropin, 11,000 iu, lyophilized vial for subcutaneous use from lots 06222017@10 (BUD 12/19/17), 09272017@14 (BUD 3/26/18), 05312017@5 (BUD 11/27/17), and 07192017@8 (BUD 1/15/18);
  • human chorionic gonadotropin, 20,000 iu, lyophilized vial for subcutaneous use from lots 06082017@33 (BUD 12/5/17), 06152017@4 (BUD 12/12/17), 07272017@4 (BUD 1/23/18), 10042017@22 (BUD 4/2/18), and 09282017@3 (BUD 3/27/18);
  • hydroquinone 8%/tretinoin 0.1% topical ointment packaged in jars from lot 08222017@37 (BUD 11/20/17);
  • hydroxocobalamin 0.5 mg/mL for diluent purpose only, 10-mL vial, from lot 10102017@9 (BUD 2/7/18);
  • hydroxocobalamin 1 mg/mL 30-mL vial for intramuscular use from lot 10162017@20 (BUD 2/13/18);
  • iodochlorhydroxyquin 3%/boric acid 10%/amphotericin 5% otic powder packaged in jars from lot 07282017@23 (BUD 1/24/18);
  • liothyronine SR (T3) 20 mcg-capsule from lots 05022017@24 (BUD 4/27/18), 10122017@21 (BUD 4/10/18), 11062017@38 (BUD 5/5/18), and 08252017@28 (BUD 8/20/18);
  • methylene blue (PF) 10 mg/mL (1%) injectable vial from lot 09252017@7 (BUD 12/24/17);
  • nicotinamide adenine dinucleotide, 500 mg, packaged in lyophilized vials for IV use from lot 06062017@3 (BUD 12/3/17);
  • oxytocin 30 units in 0.9% sodium chloride solution (PF) IV bag for IV infusion use from lots 10112017@10 (BUD 1/9/18) and 10252017@9 (BUD 1/23/18);
  • prednisolone 10-mg tablets from lot 07172017@40 (BUD 1/13/18);
  • progesterone 3% topical cream packaged in jars from lot 09212017@22 (BUD 3/20/18);
  • quad mix 16 5-mL vial from lot 05242017@25 (BUD 11/20/17);
  • quad mix 17 5-mL vial from lot 05242017@27 (BUD 11/20/17);
  • quad mix 18 5-mL vial from lot 05242017@29 (BUD 11/20/17);
  • savinase 100 mcg/mL topical solution, 1 mL in a 3-mL droptainer, from lot 06262017@31 (BUD 6/26/18); and
  • sermorelin 500 mcg orally disintegrating tablets from lot 07112017@32 (BUD 1/7/18).

The recalled products were distributed across the United States as well as in Bermuda and New Zealand.

KRS Global Biotechnology voluntarily initiated the recall November 16, 2017.

Jolynn Tumolo


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