# FDA recall D-0992-2019

> **Apotex Inc.** · Class II · drug recall initiated 2019-03-01.

## 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

- **Recall number:** D-0992-2019
- **Recalling firm:** Apotex Inc.
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0992-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0992-2019. Source: US FDA. Licensed CC0.

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