Jubilant Cadista Pharmaceuticals Inc. Issues Recall of Drospirenone and Ethinyl Estradiol Tablets, USP

Published: 07/24/2019

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

Jubilant Cadista Pharmaceuticals Inc. is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg, 28x3 Blister Pack/Carton to the consumer level. The affected product is being recalled due to out-of-specification (OOS) dissolution results at the 3-month stability time point. The affected product is manufactured by Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain under contract from Jubilant Cadista Pharmaceuticals Inc., 207 Kiley Drive Salisbury, Maryland

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