Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro,
Summary
The FDA issued a Class II for Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LL by Wedgewood Village Pharmacy, LLC. Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection.
Details
Source
Drug Recall
External ID
D-1186-2022
Action Date
2022-07-13
Status
Terminated
Category
drug
Product Description
Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Lot/Code Info: Lot#: 000-03866709 Exp Date: 09/18/22
Quantity Affected: 9/18/2022
Reason for Recall
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Distribution
Products were distributed nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-10
Company
Swedesboro, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 32 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Wedgewood Village Pharmacy, LLC has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wedgewood Village Pharmacy, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wedgewood Village Pharmacy, LLC have FDA actions?
Wedgewood Village Pharmacy, LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1186-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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