Enforcement Report - Week of June 27, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | D-1384-2012 |
| Classification | Class III |
| Code Info | Lot #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013 |
| Product Distributed Qty | 40,750 Dispensers |
| Reason For Recall | Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets. |
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 |
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