D-1456-2016 Class II Terminated

Recalled by Spectrum Laboratory Products, Inc. — New Brunswick, NJ

FDA drug recall D-1456-2016 was initiated by Spectrum Laboratory Products, Inc. on August 1, 2016 and is designated Class II. Reason for recall: Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits. The recall status is terminated (terminated April 7, 2017). Affected quantity: 14,000 grams.

Recall Details

Product Type
Drugs
Report Date
August 17, 2016
Initiation Date
August 1, 2016
Termination Date
April 7, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,000 grams

Product Description

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

Reason for Recall

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

Distribution Pattern

US: MA, TN, GA, MO and Canada

Code Information

Lot # 2EH0257