The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-017-2013·Announced 2012-10-31

Watson Recalls Necon 1/35-28 Tablets Due to Potential Cross-Contamination

Watson Laboratories is recalling Necon 1/35-28 tablets because certain lots may contain trace amounts of Hydrochlorothiazide (HCTZ). The recall covers 6,466 cartons distributed nationwide and in Puerto Rico.

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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential significant injury or property damage reports (or structural defects) are Severe. While no specific injuries are reported in the text, the presence of an unintended active ingredient (HCTZ) in a prescription drug constitutes a significant safety risk warranting a Severe rating under the Class II criteria.

Plain-English summary

Watson Laboratories Inc. is recalling Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton. The recall is due to a potential cross-contamination issue where certain lots could be contaminated with trace amounts of Hydrochlorothiazide (HCTZ). The affected product is identified by Lot # 514743AB with an expiration date of 09/30/13.

The recall involves 6,466 cartons of the medication. These products were distributed nationwide and in Puerto Rico. The recall also includes other products from the firm, specifically Zovia, Lutera, and Zenchent, which were recalled for the same potential contamination with HCTZ.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be discontinued and returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative medication options if they have been using the affected product.

The recalled product

Product
Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Pharma, Inc., A subsidiary of Watson Pharmaceuticals, Inc., Corona, CA 92880…
Manufacturer
Watson Laboratories Inc
Category
Drug — Prescription Medication
Hazard
Affected units
6,466

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 #: 514743AB
  • Exp 09/30/13

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 →

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