Sandoz Recalls Estarylla Contraceptive Tablets Due to Placebo Tablet Error
Sandoz Incorporated is recalling Estarylla tablets because a placebo tablet was found in a row of active tablets, which could reduce contraceptive effectiveness.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant injury or property damage reports, or in this case, a reasonable probability of adverse health consequences due to contraceptive failure.
Plain-English summary
Sandoz Incorporated is recalling 10,848 cartons of Estarylla (Norgestimate and Ethinyl Estradiol) Tablets, USP, 0.25mg/0.035mg. The recall was initiated after a placebo tablet was discovered in a row of active tablets, indicating a sequence error in the packaging.
The affected product is identified by Lot LF01213A with an expiration date of 02/14. The product was distributed to one consignee in Indiana. No foreign, government, VA, or military consignees were involved.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or Sandoz Incorporated for further instructions. This recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Contraceptive
- Affected units
- 10,848
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 (2)
- Lot: LF01213A
- Exp. 02/14
Distribution
Distributed in 1 state:
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