Enforcement Report - Week of June 27, 2012
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Event Detail
| Event ID | 61759 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Teva Pharmaceuticals USA, Inc. |
| City | Sellersville |
| State | PA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-23 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66. | Lot #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013 | Class III | Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets. | 40,750 Dispensers | D-1384-2012 |
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