March 2019 FDA Recall Drug by Apotex Inc.
D-0992-2019 - Contraceptive Tablets Out of Sequence

This Class II drug recall was voluntarily initiated by Apotex Inc. on March 1, 2019 for the product Drug. The FDA reported the reason for recall as contraceptive tablets out of sequence. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0992-2019

Reason for Recall
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Initiated
03-01-2019
Reported
03-13-2019
Quantity
82,705 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82288
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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