Apotex Recalls Out-of-Sequence Contraceptive Tablets
Apotex Inc. is recalling specific lots of Drospirenone and Ethinyl Estradiol tablets because they may be missing or placed incorrectly in the blister pack.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a packaging defect (out-of-sequence tablets) without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Apotex Inc. is recalling 82,705 cartons of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg. The product is packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3) and is available by prescription only. The recall covers lots 7DY008A, 7DY009A, 7DY010A, and 7DY011A, which have an expiration date of 08/2020.
The recall was initiated because the contraceptive tablets were found to be out of sequence, meaning there may be missing tablets or incorrect tablet placement within the blister pack. This defect could affect the proper administration of the medication.
The affected products were distributed nationwide in the USA. Consumers who have these specific lots should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- 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…
- Manufacturer
- Apotex Inc.
- Category
- Drug — Contraceptive
- Affected units
- 82,705
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lots: 7DY008A
- 7DY009A
- 7DY010A
- 7DY011A
- Exp. 08/2020
Distribution
Distributed nationwide across the United States.
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