Agency classClass IIOur severity:Severe FDA (Drugs)·D-016-2013·Announced 2012-10-31

Watson Recalls Necon 10/11 Tablets Due to Potential HCTZ Contamination

Watson Laboratories is recalling specific lots of Necon 10/11 oral contraceptives because they may contain trace amounts of Hydrochlorothiazide (HCTZ).

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 severity score (4) under the rubric, as it involves a potential contamination with an unintended active ingredient.

Plain-English summary

Watson Laboratories, Inc. is recalling 1,684 cartons of Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP. The affected product is packaged in 28-count dispensers, with 6 dispensers per carton, and is distributed nationwide and in Puerto Rico. The specific lot number is 512642B, with an expiration date of 08/31/13.

The recall was initiated because certain lots of Necon 10/11, along with other products including Zovia, Lutera, and Zenchent, could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). This cross-contamination occurred during the manufacturing process.

Consumers and healthcare providers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or point of purchase for disposal or replacement. Patients should consult their healthcare provider for guidance on alternative contraceptive options if they are using the affected product.

The recalled product

Product: Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson…
Manufacturer: Watson Laboratories Inc
Category: Drug — Oral Contraceptive
Hazard: cross-contamination
unintended-ingredient
Affected units: 1,684

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 # 512642B
Exp 08/31/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Watson Laboratories Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Watson Laboratories Inc

See all →

Moderate
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FDA (Drugs) · 2014-02-05
Severe
Watson Recalls Carisoprodol Tablets Due to Metal Particulates
FDA (Drugs) · 2014-01-15
Moderate
Watson Recalls Next Choice Emergency Contraceptive Tablets Due to Breakage
FDA (Drugs) · 2013-10-16
Severe
Watson Recalls Oxycodone and Acetaminophen Tablets Due to Foreign Contamination
FDA (Drugs) · 2013-10-09
Low
Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Defective Seals
FDA (Drugs) · 2013-09-25

Same hazard · cross contamination