The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-0778-2014·Announced 2013-12-25

National Enzyme Recalls Bulk DPPIV Digest Powder Due to Chloramphenicol

National Enzyme Co is recalling bulk DPPIV digest powder that may contain chloramphenicol above 0.3 ppb.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of a prohibited antibiotic residue in a dietary supplement.

Plain-English summary

National Enzyme Co is recalling Bulk A216 MRM DPPIV DIGEST BULK powder (SKU 83217) because the raw material may contain more than 0.3 ppb of chloramphenicol. The product is packaged in poly bags within corrugated boxes for domestic distribution or fiber drums for international distribution.

The recall affects 52.8 kg of powder from Lot # 83217005 and 83217006. Domestic distribution was nationwide with direct accounts in 27 states. International distribution included direct accounts in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.

Consumers and businesses should stop using the recalled product and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Bulk A216 MRM DPPIV DIGEST BULK powder (SKU 83217), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Manufacturer
National Enzyme Co

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #: 83217005 and 83217006

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 81 recalled by National Enzyme Co under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 81 products in this recall →

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