D-0628-2020 Class II Terminated
FDA drug recall D-0628-2020 was initiated by Spectrum Laboratory Products on Dec 11, 2019 and is designated Class II. Reason for recall: Subpotent Drug: Supplier indicated assay results did not meet specifications. The recall status is terminated (terminated Aug 17, 2023). Affected quantity: 6.284 kg.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 1, 2020
- Initiation Date
- Dec 11, 2019
- Termination Date
- Aug 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6.284 kg
Product Description
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.
Reason for Recall
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Distribution Pattern
Nationwide in the USA and Canada
Code Information
Lot #s: 1HG0308, 1HH0630, 1HI0854, 4HL0005,4HL0036, 4IH0032, Exp. 04/16/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0628-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026