Recalls / Class II
Class IID-1186-2022
Product
Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
- Affected lot / code info
- Lot#: 000-03866709 Exp Date: 09/18/22
Why it was recalled
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Recalling firm
- Firm
- Wedgewood Village Pharmacy, LLC
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 405 Heron Dr Ste 200, N/A, Swedesboro, New Jersey 08085-1749
Distribution
- Quantity
- 9/18/2022
- Distribution pattern
- Products were distributed nationwide in the USA.
Timeline
- Recall initiated
- 2022-06-10
- FDA classified
- 2022-07-07
- Posted by FDA
- 2022-07-13
- Terminated
- 2023-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1186-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.