Hill Dermaceuticals, Inc.: DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Man

Is my product affected?

DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20

• Brand DERMOTIC

Check against the official notice below — it lists the full affected range.

What happened

Hill Dermaceuticals, Inc. is recalling DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops in 20 mL bottles distributed nationwide in the United States because the glass pipette of the dropper may contain broken glass. The recall affects 34,561 bottles intended for sale and 773 bottles for samples across multiple lot numbers with expiration dates ranging from May 2021 through September 2022.

The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.

Details from the source

Reason for recall: Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. Distribution: Nationwide within the United States Quantity: 34,561 bottles for sale; 773 bottles for samples Lot/code info: Lot #: 19K036D, 19L039E Exp. 05/21; 20A001E, 20A003D, 20A003E, Exp. 07/21; 20C013G Exp. 09/21; 20E025F, 20E025G, 20E025H Exp. 12/21; 20H041D, 20H041F Exp. 02/22; 20J043E Exp. 03/22; 20K050F Exp. 04/22; 20L055E Exp. 06/22; 21C015E, 21C018E Exp. 09/22

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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