Recalls / Class II

Class IID-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.

Affected lot / code info

Lots: 7DY008A, 7DY009A, 7DY010A, 7DY011A, Exp. 08/2020

Why it was recalled

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

Recalling firm

Firm

Apotex Inc.

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

150 Signet Drive, N/A, North York, N/A N/A, Canada

Distribution

Quantity

82,705 cartons

Distribution pattern

Nationwide in the USA.

Timeline

Recall initiated

2019-03-01

FDA classified

2019-03-11

Posted by FDA

2019-03-13

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0992-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.