21st Century Recalls Digestive Enzymes Due to Chloramphenicol Contamination
21st Century Healthcare is voluntarily recalling Digestive Enzymes capsules because raw materials may contain trace amounts of the antibiotic chloramphenicol.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary measure due to potential trace contamination with an antibiotic, fitting the criteria for a moderate severity score.
Plain-English summary
21st Century Healthcare, Inc. is voluntarily recalling 6,483 bottles of Digestive Enzymes, 60 Capsules/Bottle. The product is sold under the brand names 21st Century Digestive Enzymes and HyVee Digestive Enzymes. The recall is initiated because the raw material used in the product may contain trace amounts of the antibiotic chloramphenicol.
The affected products have UPC codes 7-40985-22556-1 (21st Century) and 0-75450-31144-0 (HyVee). The 21st Century products have lot codes 7465500, 7465501, and 7658200, while the HyVee products have lot code 7757400. All affected bottles have an expiration date of 03/2016.
The products were distributed in Florida, Ohio, Minnesota, Washington, California, Utah, South Carolina, Tennessee, and Iowa. Consumers should stop using the product and return it to the place of purchase for a refund.
The recalled product
- Product
- Digestive Enzymes, 60 Capsules/Bottle under the following brand names: 21st Century Digestive Enzymes, 60 Capsules/Bottle. HyVee Digestive Eymes, 60 Capsules/Bottle.
- Manufacturer
- 21st Century Healthcare, Inc.
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 6,483
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 (4)
- UPC Codes: 21st Century: 7-40985-22556-1
- HyVee: 0-75450-31144-0. Lot Codes: 21st Century : 7465500
- 7465501
- 7658200. HyVee : 7757400. Expriation: 03/2016.
Distribution
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