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.
Reported: January 1, 2020 Initiated: December 11, 2019 #D-0628-2020
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.
Details
- Recalling Firm
- Spectrum Laboratory Products
- Units Affected
- 6.284 kg
- Distribution
- Nationwide in the USA and Canada
- Location
- Gardena, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Spectrum Laboratory Products. Units affected: 6.284 kg.
Why was this product recalled? ▼
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 1, 2020. Severity: Moderate. Recall number: D-0628-2020.
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