Spectrum Laboratory Products recalls
Spectrum Laboratory Products appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2023-02-01.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 9 |
|---|---|
| Published | 2014-11-26 to 2023-02-01 |
| By agency | FDA Drug (9) |
| By classification | Class II (7), Class I (2) |
| By status | terminated (9) |
| Distribution named in notices | AZ, CA, CO, FL, GA, MA, MD, MO, NJ, PA, RI, SC, TN, TX, US, UT, WY |
Recalls
- Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G
FDA Drug · Class I · 2023-02-01 · Spectrum Laboratory Products
Reason: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product - Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg
FDA Drug · Class I · 2023-02-01 · Spectrum Laboratory Products
Reason: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product - 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…
FDA Drug · Class II · 2020-02-12 · Spectrum Laboratory Products
Reason: CGMP Deviations: Presence of NDMA impurity detected in product. - Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol
FDA Drug · Class II · 2020-01-01 · Spectrum Laboratory Products
Reason: Subpotent Drug: Supplier indicated assay results did not meet specifications. - Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
FDA Drug · Class II · 2019-10-23 · Spectrum Laboratory Products
Reason: CGMP Deviations: Received notice from supplier that there is potential glass contamination. - Estradiol (17-B-Estradiol
FDA Drug · Class II · 2017-06-14 · Spectrum Laboratory Products
Reason: CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that… - Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg
FDA Drug · Class II · 2017-06-14 · Spectrum Laboratory Products
Reason: CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that… - Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
FDA Drug · Class II · 2016-08-17 · Spectrum Laboratory Products
Reason: Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits. - Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle
FDA Drug · Class II · 2014-11-26 · Spectrum Laboratory Products
Reason: CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.