Spectrum Chemical Recalls Zinc Acetate Due to Excess Lead Levels
Spectrum Laboratory Products is recalling Zinc Acetate, Crystal, USP, because it contains lead levels exceeding USP monograph limits.
The agency’s classification
FDA (Drugs): 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 and involves a significant chemical contamination (lead) that exceeds safety limits, meeting the criteria for a Severe rating.
Plain-English summary
Spectrum Laboratory Products, Inc. is recalling Zinc Acetate, Crystal, USP, packaged in 500 gram bottles. The recall involves 14,000 grams of the product from Lot # 2EH0257. The product was distributed in Massachusetts, Tennessee, Georgia, Missouri, and Canada.
The recall was initiated because the product does not meet the USP monograph, specifically exhibiting lead levels in excess of the established limits. The FDA has classified this recall as Class II.
Consumers who have purchased this specific lot of Zinc Acetate should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
- Manufacturer
- Spectrum Laboratory Products, Inc.
- Category
- Drug — Pharmaceutical Excipient
- Hazard
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 # 2EH0257
Distribution
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