Why it was recalled
Subpotent Drug: Supplier indicated assay results did not meet specifications.
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.
Lot numbers, UPCs & expiration codes
Lot #s: 1HG0308, 1HH0630, 1HI0854, 4HL0005,4HL0036, 4IH0032, Exp. 04/16/2021
Where it was sold
Nationwide in the USA and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0628-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 11, 2019
- FDA report date
- Jan 1, 2020
- Quantity
- 6.284 kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Spectrum Laboratory Products
Original FDA data
Every field from FDA enforcement report D-0628-2020, exactly as published.
Show all FDA fields
- City
- Gardena
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84509
- Address
- 14422 S San Pedro St
- Code information
- Lot #s: 1HG0308, 1HH0630, 1HI0854, 4HL0005,4HL0036, 4IH0032, Exp. 04/16/2021
- Postal code
- 90248-2027
- Report date
- Jan 1, 2020
- Product type
- Drugs
- Recall number
- D-0628-2020
- Classification
- Class II
- Recalling firm
- Spectrum Laboratory Products
- Product quantity
- 6.284 kg
- Termination date
- Aug 17, 2023
- Reason for recall
- Subpotent Drug: Supplier indicated assay results did not meet specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA and Canada
- Recall initiation date
- Dec 11, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2019