FDA recall record

Abbott Nutrition The product is labeled as follows: PediaSure Grow & Gain recall — FDA F-1041-2016

Abbott Nutrition is recalling PediaSure Grow & Gain Vanilla is product because the product may have a different color, smell, taste or texture …

Class IIclassification
F-1041-2016official record ID
Apr 13, 2016report date

Recall record at a glance

Official recordF-1041-2016
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmAbbott Nutrition
Report dateApr 13, 2016
Recall initiation dateMar 10, 2016
Quantity15,609 cases (374,616 units)
LocationAltavista, VA, United States

Official 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 .

Why the product 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

Distribution information

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.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Telephone.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.

Related recall records

Other records from the same recalling company are shown first when available.