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D-0992-2019 Class II

Recalled by Apotex Inc. — North York, N/A

FDA drug recall D-0992-2019 was initiated by Apotex Inc. on Mar 1, 2019 and is designated Class II. Reason for recall: Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. Affected quantity: 82,705 cartons.

Recall details

Product Type: Drugs
Report Date: Mar 13, 2019
Initiation Date: Mar 1, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 82,705 cartons

Product description

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 pattern

Nationwide in the USA.

Code information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0992-2019
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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