Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

Class IHigh

FDANov 20, 2019Nationwide• AuroMedics Pharma LLC

Mirtazapine Tablets 7.5mg (AuroMedics) – Labeling Error (2019)

Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

Class IHigh

FDANov 20, 2019Nationwide• AuroMedics Pharma LLC

Gabapentin Capsules (AuroMedics) – Foreign Tablet Contamination (2019)

Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..

Class IIModerate

FDANov 19, 2019Nationwide• AuroMedics Pharma LLC

Sodium Chloride Irrigation (Baxter) – Sterility Risk (2019)

Lack of Assurance of Sterility: Product has the potential to leak.

Class IIModerate

FDANov 19, 2019Nationwide• Baxter Healthcare Corporation

Timolol Maleate Ophthalmic Solution (Rising) – Labeling Mix-up (2019)

Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.

Class IIILow

FDANov 15, 2019Nationwide• Rising Pharmaceuticals, Inc.

Timolol Maleate Ophthalmic Solution (Rising) – Labeling Error (2019)

Class IIILow

FDANov 15, 2019Nationwide• Rising Pharmaceuticals, Inc.

Clobetasol Propionate Foam (Glenmark) – Delivery System Failure (2019)

Defective delivery system; product is not foaming or is coming out as liquid.

Class IIILow

FDANov 15, 2019Nationwide• Glenmark Pharmaceuticals Inc., USA

Clobetasol Propionate Foam (Glenmark) – Defective Delivery System (2019)

Defective delivery system; product is not foaming or is coming out as liquid.

Class IIILow

FDANov 15, 2019Nationwide• Glenmark Pharmaceuticals Inc., USA

Myorisan Isotretinoin Capsules (Akorn) – Mispackaging Issue (2019)

Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.

Class IIModerate

FDANov 15, 2019Nationwide• Akorn, Inc.

ALOCANE Emergency Burn Pads (Quest Products) – Child Safety Issue (2019)

Fire/Burn Risk

This recall involves the ALOCANE® Emergency Burn Pads (10 count and 15 count) which come in a white and red box with "MAXIMUM STRENGTH ALOCANE® Emergency Burn Pads" printed on the front. The product is an over the counter Gel Infused Pad with lidocaine (4%) as the active ingredient. The pads are sold in a 10 count box and 15 count box with the lot numbers 4179, 4180, 4235, 4645, 4646 or 4698 printed next to the barcode on the box. The UPC number for the affected product is 8-46241-02448-7 and can be found on the bottom of the box.

CPSCNov 14, 2019Nationwide• Quest Products LLC, of Pleasant Prairie, Wis.