Reported Jun 15, 2016 · Terminated
CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy…
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?
- CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 02012016:74@35, Exp. 07/31/2016 2 Lot #:02102016:40@16, Exp.08/09/2016 3 Lot #: 02242016:73@41, Exp. 08/23/2016 4 Lot #: 03102016:64@53, Exp.09/07/2016 5 Lot #:04052016:70@16 Exp. 10/02/2016 6 Lot #: 04222016:85@37, Exp.10/22/2016. - Amount recalled
- 916 total
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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