Reported Jun 15, 2016 · Terminated
ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV…
Well Care Compounding Pharmacy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Well Care Compounding Pharmacy · 3430 E Tropicana Ave Ste 9 · Las Vegas, NV · 89121-7345
Is this the product you have?
ATROPINE SULFATE 0.5% Ophthalmic Dropspackaged in 5mL droppersRx onlyWell Care Compounding Pharmacy Las VegasNV 89121
- Lot codes and dates
Lot #: 03252016:11 @26Exp. 05/07/2016Lot #: 04042016:28 @39Exp. 05/06/2016Lot #: 02102016:00 @22Exp. 03/24/2016Lot #:02112016:08 @13Exp. 03/16/2016
- Amount recalled
- 869 Units (All Products)
This recall covers 51 products
The agency filed one notice per product. You are reading one of them; the other 50 are below.
38 more are in the archive.
Where it was sold
Why it was recalled
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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