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Class II: temporary or reversible health riskTerminated

Abbott Nutrition The product is labeled as follows: PediaSure Recall

The product is labeled as follows: PediaSure Grow & Gain Vanilla, Unit size : 8 oz

Abbott Nutrition · Altavista, VA

Risk level
Class II
Reported by FDA
Apr 13, 2016
Recall ID
F-1041-2016
Check your lot numberHow we source this data

Summary

Abbott Nutrition recalled The product is labeled as follows: PediaSure starting Mar 10, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-1041-2016 on Apr 13, 2016. Reason: Abbott Nutrition is recalling PediaSure Grow & Gain Vanilla is product because the product may have a different color, smell, taste or texture  inconsistent with other lots of PediaSure Grow & Gain Vanilla. Abbott Nutrition also recognized a complaint trend for physical stability and sensory on this batch on 1/25/16 and an investigation revealed a possibility that a small portion of cans may. Status: Terminated.

Why it was recalled

Abbott Nutrition is recalling PediaSure Grow & Gain Vanilla is product because the product may have a different color, smell, taste or texture  inconsistent with other lots of PediaSure Grow & Gain Vanilla. Abbott Nutrition also recognized a complaint trend for physical stability and sensory on this batch on 1/25/16 and an investigation revealed a possibility that a small portion of cans may

Product description

The product is labeled as follows: PediaSure Grow & Gain Vanilla, Unit size : 8 oz. , Container description : Metal Can, Total package size : 24 cans per case .

Lot numbers, UPCs & expiration codes

List Number 55897 , Lot 57642RA00

Where it was sold

Lot 57642RA00, Beginning Date of distribution in US  10/12/15 End Date of distribution in US- 12/4/15 . AN distributed this lot to151 Distributors, 32 Medical Facilities and 25 Other types of consignees (2 of these were internal sales reps). No foreign accounts. There are 12 US government consignees.

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-1041-2016
Classification
Class II
Status
Terminated
Recall initiated
Mar 10, 2016
FDA report date
Apr 13, 2016
Quantity
15,609 cases (374,616 units)
Recall type
Voluntary: Firm initiated
Recalling firm
Abbott Nutrition

Original FDA data

Every field from FDA enforcement report F-1041-2016, exactly as published.

Show all FDA fields
City
Altavista
State
VA
Status
Terminated
Country
United States
Event ID
73499
Address
1518 Main St
Code information
List Number 55897 , Lot 57642RA00
Postal code
24517-1132
Report date
Apr 13, 2016
Product type
Food
Recall number
F-1041-2016
Classification
Class II
Recalling firm
Abbott Nutrition
Product quantity
15,609 cases (374,616 units)
Termination date
Nov 1, 2016
Reason for recall
Abbott Nutrition is recalling PediaSure Grow & Gain Vanilla is product because the product may have a different color, smell, taste or texture  inconsistent with other lots of PediaSure Grow & Gain Vanilla. Abbott Nutrition also recognized a complaint trend for physical stability and sensory on this batch on 1/25/16 and an investigation revealed a possibility that a small portion of cans may
Voluntary / mandated
Voluntary: Firm initiated
Product description
The product is labeled as follows: PediaSure Grow & Gain Vanilla, Unit size : 8 oz. , Container description : Metal Can, Total package size : 24 cans per case .
Distribution pattern
Lot 57642RA00, Beginning Date of distribution in US  10/12/15 End Date of distribution in US- 12/4/15 . AN distributed this lot to151 Distributors, 32 Medical Facilities and 25 Other types of consignees (2 of these were internal sales reps). No foreign accounts. There are 12 US government consignees.
Recall initiation date
Mar 10, 2016
Initial firm notification
Telephone
Center classification date
Apr 6, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1041-2016, published Apr 13, 2016. View the source record (openFDA) · FDA enforcement reports

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

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