FDA recall D-0992-2019

Product

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.

Reason for recall

Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.

Distribution

Nationwide in the USA.

Key facts

Status

Completed

Initiation date

2019-03-01

Report date

2019-03-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

North York, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0992-2019