Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Estradiol (17-B-Estradiol; Estra-1,3,5(10)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435.
Drug: Estradiol
- Recalling firm
- Spectrum Laboratory Products, Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0881-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Estradiol recalls
See all
Class II · Moderate risk
Estradiol Gel
Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Other recalls by Spectrum Laboratory Products, Inc.
All 2017 recalls
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class II · Moderate risk
Ranitidine Hydrochloride
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Estriol
Subpotent Drug: Supplier indicated assay results did not meet specifications.
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