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Spectrum Laboratory Products

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20141
20191
20202
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FDA Recall Terminated Historical recordClass II

Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram

by Spectrum Laboratory Products

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
February 12, 2020
Distribution
The recalled API was distributed to phar…

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FDA Recall Terminated Historical recordClass II

Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.

by Spectrum Laboratory Products

Reason
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Published
January 1, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06

by Spectrum Laboratory Products

Reason
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Published
October 23, 2019
Distribution
Product was distributed to compounding p…

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FDA Recall Terminated Historical recordClass II

Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.

by Spectrum Laboratory Products

Reason
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Published
November 26, 2014
Distribution
U.S.: California.

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Showing 1–4 of 4 results

This page lists recalls that name Spectrum Laboratory Products as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.