Reported Jun 30, 2021 · Terminated
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals,…
Hill Dermaceuticals, Inc.
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: Hill Dermaceuticals, Inc. · 2650 S Mellonville Ave · Sanford, FL · 32773-9311
Is this the product you have?
- DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only
- Manufactured byHill Dermaceuticals, Inc. Sanford
- FL 32773 for
Royal Pharmaceuticals ManasquanNJ 08736NDC 68791-103-20
- Lot codes and dates
Lot #: 19K036D19L039E Exp. 05/2120A001E20A003D20A003EExp. 07/2120C013G Exp. 09/2120E025F20E025G20E025H Exp. 12/2120H041D20H041F Exp. 02/2220J043E Exp. 03/2220K050F Exp. 04/2220L055E Exp. 06/2221C015E21C018E Exp. 09/22
- Amount recalled
- 34,561 bottles for sale; 773 bottles for samples
Where it was sold
- Nationwide
Why it was recalled
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
This product could cause temporary or reversible health problems — stop using it.
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