Gardena, CA, United States
Spectrum Laboratory Products recalls
4 recalls recorded since 2018, most recently on 19 December 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)1
Terminated Class I Drugs
- Recall started
- 19 December 2022
- Terminated
- 19 August 2025
- Reason
- Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
- Distribution
- Nationwide in the USA, Puerto Rico and Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0179-2023, D-0180-2023
- 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. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130
- Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Br
Terminated Class II Drugs
- Recall started
- 14 January 2020
- Terminated
- 5 December 2023
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Distribution
- The recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0825-2020
- 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
Terminated Class II Drugs
- Recall started
- 11 December 2019
- Terminated
- 17 August 2023
- Reason
- Subpotent Drug: Supplier indicated assay results did not meet specifications.
- Distribution
- Nationwide in the USA and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0628-2020
- 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 bott
Terminated Class II Drugs
- Recall started
- 12 September 2019
- Terminated
- 10 November 2020
- Reason
- CGMP Deviations: Received notice from supplier that there is potential glass contamination.
- Distribution
- Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0141-2020
- Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.