Class II
Terminated
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.
This recall has been terminated (originally issued January 1, 2020).
- Company
- Spectrum Laboratory Products
- Recall Initiated
- December 11, 2019
- Posted
- January 1, 2020
- Recall Number
- D-0628-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6.284 kg
- Firm Location
- Gardena, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Distribution
Nationwide in the USA and Canada
Lot / Code Info
Lot #s: 1HG0308, 1HH0630, 1HI0854, 4HL0005,4HL0036, 4IH0032, Exp. 04/16/2021
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