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Recall Observatory FDA recall evidence

Drug product

Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901

D-1456-2016

August 01, 2016

Class II

Product summary

Firm
Spectrum Laboratory Products, Inc.
Event
Event 74888
Status
Terminated
Classification
Class II
Quantity
14,000 grams
Official record key
drug-enforcement:D-1456-2016

Official wording

Reason: Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.

Code information: Lot # 2EH0257

Distribution pattern: US: MA, TN, GA, MO and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.