Drug product
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.
D-0628-2020
Product summary
- Event
- Event 84509
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6.284 kg
- Official record key
drug-enforcement:D-0628-2020
Official wording
Reason: Subpotent Drug: Supplier indicated assay results did not meet specifications.
Code information: Lot #s: 1HG0308, 1HH0630, 1HI0854, 4HL0005,4HL0036, 4IH0032, Exp. 04/16/2021
Distribution pattern: Nationwide in the USA and Canada
Derived failure modes
-
Potency or specification failure
Subpotent