Class IITerminated · reported 2016-04-13

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

Abbott Nutrition recalled this product and the FDA reported the enforcement action on 13 April 2016 as Class II. The recall was initiated by the firm. 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

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product: 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 .
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
Recalling firm: Abbott Nutrition
Firm location: Altavista, Virginia, United States
Classification: Class II
Status: Terminated
Recall number: F-1041-2016
Quantity: 15,609 cases (374,616 units)
Distribution: 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.
Initiated: 10 March 2016
Reported by FDA: 13 April 2016
Terminated: 1 November 2016
Firm notified by: Telephone
Product codes: List Number 55897 , Lot 57642RA00

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 8 months, from 10 March 2016 to termination on 1 November 2016. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
The FDA published the enforcement report 5 weeks after the firm began the recall.
The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Other records from Abbott Nutrition

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 8 other records name this firm.

Reported	Product	Firm	Reason	Class
2022-09-07	Similac Alimentum packaged in 32 fluid ounce re-closable plastic bottles 6 bottles per case	ABBOTT NUTRITION	Packaging defect	Class II
2017-02-08	Nepro Vanilla , 8oz metal can	Abbott Nutrition	The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.	Class II
2017-02-08	Oxepa, 8oz metal can	Abbott Nutrition	The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.	Class II
2017-02-08	Vital High Protein, 8oz metal can	Abbott Nutrition	The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.	Class II
2017-02-08	Nepro Vanilla High Protein , 8oz metal can	Abbott Nutrition	The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.	Class II
2017-02-08	Nepro Mixed Berry, 8oz metal can	Abbott Nutrition	The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.	Class II
2017-02-08	Promote with Fiber Vanilla, 8oz metal can	Abbott Nutrition	The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.	Class II
2014-02-26	Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)*CONTAINS MILK AND SOY INGREDIENTSUSE BY**ABBOTT LABORATORIES"	Abbott Nutrition	Abbott Nutrition (AN) recalled this product from the Canadian market because some of the packets may have an incomplete seal which could allow air to enter the packet causing food oxidation and/or the powder to leak	Class II

All 9 records for Abbott Nutrition

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