Why it was recalled
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Product description
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 USA; NDC 52544-552-28.
Lot numbers, UPCs & expiration codes
Lot #: 514743AB, Exp 09/30/13
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-017-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 19, 2012
- FDA report date
- Oct 31, 2012
- Quantity
- 6,466 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Watson Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-017-2013, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 63509
- Address
- 311 Bonnie Cir
- Code information
- Lot #: 514743AB, Exp 09/30/13
- Postal code
- 92880-2882
- Report date
- Oct 31, 2012
- Product type
- Drugs
- Recall number
- D-017-2013
- Classification
- Class II
- Recalling firm
- Watson Laboratories Inc
- Product quantity
- 6,466 cartons
- Termination date
- Nov 21, 2013
- Reason for recall
- Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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 USA; NDC 52544-552-28.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Oct 19, 2012
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2012