FDA Drug recall D-0992-2019
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…
- FDA Drug
- Class II
- completed
- Published 2019-03-13
On 2019-03-13 the FDA classified a Class II recall of 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… by Apotex, citing contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0992-2019 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-03-01 |
| Published | 2019-03-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | US |
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
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Identifiers
| code_info | Lots: 7DY008A, 7DY009A, 7DY010A, 7DY011A, Exp. 08/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
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FDA Drug · Class II · 2026-09-02 · Apotex - Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg…
FDA Drug · Class II · 2026-04-22 · Apotex - Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp
FDA Drug · Class II · 2026-03-25 · Apotex - Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C…
FDA Drug · Class II · 2025-10-08 · Apotex
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0992-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.