Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distr

FDA recall notice · announced August 7, 2019 · Jubilant Cadista Pharmaceuticals

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43

Reason for recall

Failed dissolution specifications : failed results at the 3-month stability time point.

Notes

Distribution: USA Nationwide
Lot/code information: Lot #: 183222, Exp 11/2020
Quantity: 11,412 cartons/34,236 blister cards/28 tablets each card
Status: Terminated
Products in this recall event:
- Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: (D-1837-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.