Food recall

ProThera, Inc. recall: Serralase Enzyme Supplements

ProThera, Inc., of Reno, NV, recalled Serralase Enzyme Supplements and 4 other products. The FDA's reason: “ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on October 10, 2013, and the FDA first listed it in its Enforcement Report of November 20, 2013. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

See FDA's words below

Status

Terminated

Closed February 24, 2014

The recall

Company
ProThera, Inc. (Reno, NV)
Reason, in FDA's words
“ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.”
Where it was sold
US and Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland (Eire, Japan, Malaysia, Malta, Mexico, New Zealand, Panama, Philippines, Russia, South Korea, Spain, Switzerland, Thailand.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
66553

The 5 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0158-2014 Class II

    Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 28054 00149 7; Manufactured by: ProThera, Inc., Reno, NV 89521

    Codes: Lot F3994

    Quantity: 27,480

  • F-0159-2014 Class II

    Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement; 180 Chewable tablets. UPC 7 09616 0218 5 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521

    Codes: Lot F3990 and C3516

    Quantity: 82,746 lot F3990 and 988.200 of lot C3516.

  • F-0160-2014 Class II

    Klaire Labs Vital-Zymes complete; Comprehensive Enzyme Supplement; 120 Vegetarian tablets. UPC 790616310005 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521

    Codes: Lot #'s 0613110, 0513156 and 0513157

    Quantity: 187,941 lot 0613110; 491.232 lot 0513156 and 504864 lot 0513157

  • F-0161-2014 Class II

    Klaire Labs Interfase; Enzyme Supplement; Packaged in 60 and 120 Vegetarian capsules bottles. UPC 60 ct.- 7 0961 012270 7; UPc 120 ct. - 7 09616-01229 1 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521

    Codes: Lot #' 313127

    Quantity: 243,851

  • F-0162-2014 Class II

    Klaire Labs Interfase Plus; Enzyme Supplement; 120 Vegetarian capsules bottles. UPC 7 09616 01228 4 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521 Notation: Product #6 Clean Cut Enzyme wasn't entered into RES because the product never left the warehouse.

    Codes: Lot #'s 0913039, 0913040, and 0413085

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of November 20, 2013.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.