Status
Terminated
Drug Enforcement D-1441-2012
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
Classification
Class III
Report Date
August 8, 2012
Termination Date
July 16, 2013
Product Information
- 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,
- Product quantity
- 13,128 bottles
- 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
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Michigan
Location & Firm
- Recalling firm
- Axcentria Pharmaceuticals LLC
- Address
-
306 Keystone Dr, Unit B
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1441-2012
- Event ID
- 62628
- Recall initiation date
- July 12, 2012
- Center classification date
- August 2, 2012
- Code info
- Lot D12044, Exp 4/2014, NDC 0904-5255-30
- More code info
- —