Class II · Moderate risk
Progesterone Injection USP
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Progesterone 50 mg Modified Release Capsule
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls (lack of assurance of conformity to specifications).
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
Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Drug: Progesterone
- Recalling firm
- MasterPharm LLC
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1432-2020 · 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 Progesterone recalls
See all
Class II · Moderate risk
Progesterone Injection
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class II · Moderate risk
Progesterone 200 mg
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Class II · Moderate risk
Endometrin
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Progesterone-Gs Oil- 100mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Other recalls by MasterPharm LLC
All 2020 recalls
Class II · Moderate risk
Yohimbine HCL 5.4mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Vardenafil 20 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Testosterone/Anastrozole Pellet 100/6 mg
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tadalafil 7 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
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