Product Recalls: May 10, 2018 – June 13, 2018

Health Letter, July 2018

CLASS II

Acetaminophen with codeine phosphate tablets, 300 mg/30 mg, 20-count M-Pak containers. Manufactured for: Aurobindo Pharma USA, Inc or Mallinckrodt Inc.

Amlodipine and benazapril HCL capsules, 5 mg/10 mg or 5 mg/40 mg, 100-count bottles. Manufactured by: Mylan Pharmaceuticals, Inc.

Azithromycin tablets, 250 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Capecitabine tablets, 150 or 500 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Clindamycin capsules, 150 or 300 mg, 30-count M-Pak container. Manufactured by: Lannett Co. Inc.

Creon DR, 24,000-unit capsules, 30-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Cyclophosphamide capsules, 50 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Dexamethasone tablets, 4 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Diclofenac sodium and misoprostol delayed-release tablets, 75 mg/0.2 mg, 60-count bottle. Manufactured by: Cipla Ltd.

Gleevec tablets, 100 mg, 30-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Ibrance capsules, 125 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Imatinib mesylate tablets, 400 mg, 30-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Kalydeco tablets, 150-mg tablet blister, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Kisqali tablets, 200 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Letrozole tablets, 2.5 mg, 30-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Loxapine capsules, 25 or 50 mg, 100-count bottles. Manufactured by: Mylan Pharmaceuticals Inc.

Metoprolol succinate extended-release tablets, 100 mg, 100-count bottle. Manufactured by: Dr. Reddy’s Laboratories Limited

My Way (levonorgestrel) tablets, 1.5 mg, packaged as 2 treatments (two 1.5-mg levonorgestrel tablets) per carton. GAVIS Pharmaceuticals, A Lupin Group Company; Manufactured for Lupin Pharmaceuticals, Inc. or Lupin Limited.

Ondansetron tablets, 8 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Orkambi tablets, 200 mg/125 mg or 100 mg/125 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Otezla tablets, 30 mg, 30-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Pomalyst capsules, 3 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

PrednisoLONE sodium phosphate orally disintegrating tablets; 10, 15 or 30 mg; 48-count bottle. Manufactured by: Mylan Pharmaceuticals Inc.

Promacta tablets, 50 mg, 30-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Revlimid oral capsules; 5, 10, 15, 20 or 25 mg; 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Sprycel tablets, 80 or 100 mg, 30-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Sulfamethoxazole and trimethoprim tablets, 800 mg/160 mg, 500-count bottle. Manufactured by: Frontida BioPharm, Inc.

Sutent capsules, 37.5 or 50 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Tasigna capsules, 150 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Tecfidera capsules, 240 mg, 30-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Temozolomide capsules, 20 or 250 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Vosevi tablets, 400/100/100 mg, 28-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Xalkori capsules, 250 mg, 30-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

Xtandi capsules, 40 mg, 30-day supply. Manufactured by: Kroger Specialty Pharmacy, Inc.

For more information about the drug recalls listed above, please visit http://www.accessdata.fda.gov/scripts/ires/index.cfm.

CONSUMER PRODUCTS

For a list of recent recalls of consumer products, please visit the Consumer Product Safety Commission website at http://www.cpsc.gov/en/Recalls/.