Class II · Moderate risk
Progesterone Injection USP
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Bi-Est
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Control
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
Bi-Est (50/50/Progesterone 0.2 mg/70 mg Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Drug: Progesterone
- Recalling firm
- The Medicine Shoppe Pharmacy
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1216-2020 · 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 The Medicine Shoppe Pharmacy
All 2020 recalls
Class II · Moderate risk
Levothyroxin
Lack of Processing Control
Class II · Moderate risk
Betahistine 16 mg Capsule 180 capsules bottle
Lack of Processing Control
Class II · Moderate risk
Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository
Lack of Processing Control
Class II · Moderate risk
Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar
Lack of Processing Control
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