Status
Terminated
Drug Enforcement D-1397-2012
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
Classification
Class II
Report Date
July 4, 2012
Termination Date
April 10, 2013
Product Information
- Product description
- Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs
- Product quantity
- 100,761 cartons
- Reason for recall
- Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Address
-
650 Cathill Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1397-2012
- Event ID
- 61776
- Recall initiation date
- May 2, 2012
- Center classification date
- June 26, 2012
- Code info
- Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013
- More code info
- —