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Class II: temporary or reversible health riskTerminated

Cardinal Health Dairy Aid Lactase Enzyme Supplement Recall

Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackag…

Cardinal Health · Zanesville, OH

Risk level
Class II
Reported by FDA
Jan 30, 2013
Recall ID
F-0916-2013
Check your lot numberHow we source this data

Summary

Cardinal Health recalled Dairy Aid Lactase Enzyme Supplement starting Nov 13, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-0916-2013 on Jan 30, 2013. Reason: The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet. Status: Terminated.

Why it was recalled

The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet.

Product description

Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4

Lot numbers, UPCs & expiration codes

White, oblong caplet, imprinted RP143; Batch# M675030, Lot # 10627AA, Exp Date 11/2012; Batch# M679370, Lot # 10627BA, Exp Date 12/2012; Batch# M675020, Lot # 10627A, Exp Date 11/2012; Batch# M679360, Lot # 10627B, Exp Date 12/2012; Batch# M707960, Lot # 10627C, Exp Date 3/2013; Batch# M712800, Lot # 11469A, Exp Date 3/2013; Batch# M740490, Lot # 11464B, Exp Date 6/2013 & Batch# M743510, Lot # 13973A, Exp Date 7/2013.

Where it was sold

Product was shipped to the following states: NJ & NY

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-0916-2013
Classification
Class II
Status
Terminated
Recall initiated
Nov 13, 2012
FDA report date
Jan 30, 2013
Quantity
1,140 caplets
Recall type
Voluntary: Firm initiated
Recalling firm
Cardinal Health

Original FDA data

Every field from FDA enforcement report F-0916-2013, exactly as published.

Show all FDA fields
City
Zanesville
State
OH
Status
Terminated
Country
United States
Event ID
63955
Address
3540 East Pike
Code information
White, oblong caplet, imprinted RP143; Batch# M675030, Lot # 10627AA, Exp Date 11/2012; Batch# M679370, Lot # 10627BA, Exp Date 12/2012; Batch# M675020, Lot # 10627A, Exp Date 11/2012; Batch# M679360, Lot # 10627B, Exp Date 12/2012; Batch# M707960, Lot # 10627C, Exp Date 3/2013; Batch# M712800, Lot # 11469A, Exp Date 3/2013; Batch# M740490, Lot # 11464B, Exp Date 6/2013 & Batch# M743510, Lot # 13973A, Exp Date 7/2013.
Postal code
43701
Report date
Jan 30, 2013
Product type
Food
Recall number
F-0916-2013
Classification
Class II
Recalling firm
Cardinal Health
Product quantity
1,140 caplets
Termination date
Jul 2, 2013
Reason for recall
The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4
Distribution pattern
Product was shipped to the following states: NJ & NY
Recall initiation date
Nov 13, 2012
Initial firm notification
Letter
Center classification date
Jan 23, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-0916-2013, published Jan 30, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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