HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Formula Products, Hemp Pea Protein: FDA Health And Wellness Recalls

This article was originally published in The Rose Sheet

Executive Summary

Abbott Nutrition, West Coast Laboratories and Del Dee Foods nutritional product recalls were included in FDA's Feb. 8 enforcement database update.

FEB. 8: FOOD-CLASS II

1) Promote with Fiber Vanilla, 8-ounce metal can; 2) Oxepa, 8-ounce metal can; 3) Nepro Vanilla High Protein, 8-ounce metal can; 4) Nepro Vanilla, 8-ounce metal can; 5) Vital High Protein, 8-ounce metal can; 6) Nepro Mixed Berry, 8-ounce metal can; 7) PediaSure Grow & Gain Vanilla [reported to FDA in March 2016], Unit size: 8-ounce, Container description : Metal Can, Total package size : 24 cans per case.

Code: 1) Lot Number 57643RA00/01/02 Expiration Date 1Oct 2016; 2) Lot Number 57648RA00 Expiration Date 1Jan1017; 3) Lot Number 57648RA11 Expiration Date 1Jan 2017; 4) Lot Number 57447RA00 Expiration Date 1Oct2016; 5) Lot Number 59879RA00 Expiration Date 1Dec2016; 6) List Number 55897 , Lot 57642RA00.

Manufacturer:

Abbott Nutrition, Altavista, VA

Recalled by:

Abbott Nutrition by two or more of email, fax, letter, press release, telephone or visit on May 9, 2016, for items 1-6; by telephone on Marcy 10, 2016, for item 1. Voluntary recalls are completed.

Distribution:

Items 1-6: products were distributed in the US, including Guam and Puerto Rico, Israel, Kuwait, Trinidad and Tobago; item 7: to151 distributors, 32 medical facilities and 25 other types of consignees, including 12 US government consignees; no foreign accounts; 1) 262,608 units, 2) 45,156, 3) 37,584, 4) 332,088, 5) 31,440, 6) 362,400, 7) 5,609 cases (374,616 units).

Reason:

Abbott Nutrition in May expanded a recall initially reported to FDA in March 2016 PediaSure Grow & Gain Vanilla to include additional products recalled because of off odor and taste due to microbial contamination.

Recall numbers:

F-1419-2017 through F-1424-2017, F-1041-2016

Xambo, 80 boxes of bulk capsules. Each containing 12,053 capsules in each box; Devagrass [no other description published by FDA on this recalled product].

Code: 1) 361215, 2) 620815.

Manufacturer:

West Coast Laboratories Inc., Gardena, CA

Recalled by:

West Coast Laboratories by letter on Jan. 11, 2017. Voluntary recall is ongoing.

Distribution:

Colombia, South America; 1) 80 boxes/12,053 capsules per box, 2) 3,600 blisters.

Reason:

West Coast Laboratories is recalling Xambo and Devagrass because there may be presence of 1,3-dimethylamylamine (DMAA).

Recall numbers:

F-1430-2017, F-1431-2017

FOOD-CLASS I

Hemp & Grain Co. Organic Pea Protein 80%, Net Weight 44.1 lbs. Paper bags, 36 paper bags/pallet.

Code: Lot# PP33116-0-D.

Manufacturer:

Del Dee Foods Inc., Appleton, MN

Recalled by:

Del Dee Foods by two or more of email, fax, letter, press release, telephone or visit on Jan. 3, 2017. Voluntary recall is ongoing.

Distribution:

US; MN, CA, NJ, WI. And CANADA; 50,626.8 pounds.

Reason:

Del Dee Foods withdrew Lot# PP33116-0-D after receiving a report of salmonella found in two sample tests taken from product in the lot before it reached customer.

Recall numbers:

F-1383-2017

EDITORS’ NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS109109

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel