D-1441-2012 Class III Terminated
FDA drug recall D-1441-2012 was initiated by Axcentria Pharmaceuticals LLC on July 12, 2012 and is designated Class III. Reason for recall: Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014 The recall status is terminated (terminated July 16, 2013). Affected quantity: 13,128 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 8, 2012
- Initiation Date
- July 12, 2012
- Termination Date
- July 16, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,128 bottles
Product Description
Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30,
Reason for Recall
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
Distribution Pattern
Michigan
Code Information
Lot D12044, Exp 4/2014, NDC 0904-5255-30