Agency classClass IIOur severity:Moderate FDA (Drugs)·D-013-2013·Announced 2012-10-31

Watson Recalls Zovia Tablets Due to Potential Cross-Contamination

Watson Laboratories is recalling Zovia tablets because certain lots may contain trace amounts of Hydrochlorothiazide (HCTZ) due to cross-contamination.

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 potential cross-contamination with trace amounts of another drug without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Watson Laboratories, Inc. is recalling specific lots of Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP. The recall was initiated because certain lots of Zovia, along with other products including Lutera, Necon, and Zenchent, could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ) due to cross-contamination.

The affected product is Zovia Tablets USP, 1 mg/35 mcg, packaged in 28-count dispensers with 6 dispensers per carton. The recall covers 30,267 cartons distributed nationwide and in Puerto Rico. The specific lots affected are 515622AA, 515623AA, and 515623BA, all with an expiration date of 09/30/13.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be discontinued and returned to the distributor or manufacturer for further instructions.

The recalled product

Product: Zovia (ethynodiol diacetate 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 Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.…
Manufacturer: Watson Laboratories Inc
Category: Drug — Oral Contraceptive
Hazard: cross-contamination
foreign-substance
Affected units: 30,267

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 (4)

Lot #: 515622AA
515623AA
and 515623BA
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 →

Same manufacturer · Watson Laboratories Inc

See all →

Moderate
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Severe
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Moderate
Watson Recalls Next Choice Emergency Contraceptive Tablets Due to Breakage
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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