Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.

Jan 10, 2024 Other Drugs Nationwide View Details →

Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials

OMEZA

Class I - Dangerous

CGMP Deviations

Jan 19, 2024 Other Drugs Nationwide View Details →

EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01

Kilitch Healthcare India Limited

Class I - Dangerous

Non-Sterility

Nov 13, 2023 Other Drugs Nationwide View Details →

Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017

Kilitch Healthcare India Limited

Class I - Dangerous

Non-Sterility

Nov 13, 2023 Other Drugs Nationwide View Details →

Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1

Kilitch Healthcare India Limited

Class I - Dangerous

Non-Sterility

Nov 13, 2023 Other Drugs Nationwide View Details →

Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94

Kilitch Healthcare India Limited

Class I - Dangerous

Non-Sterility

Nov 13, 2023 Other Drugs Nationwide View Details →

Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3

Kilitch Healthcare India Limited

Class I - Dangerous

Non-Sterility

Nov 13, 2023 Other Drugs Nationwide View Details →

Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5

Kilitch Healthcare India Limited

Class I - Dangerous

Non-Sterility

Nov 13, 2023 Other Drugs Nationwide View Details →

Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1

Kilitch Healthcare India Limited

Class I - Dangerous

Non-Sterility

Nov 13, 2023 Other Drugs Nationwide View Details →

Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid

Kilitch Healthcare India Limited

Class I - Dangerous

Non-Sterility

Nov 13, 2023 Other Drugs Nationwide View Details →

VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.

Denver Solutions, LLC

Class I - Dangerous

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Dec 28, 2023 Other Drugs Nationwide View Details →

FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.

Denver Solutions, LLC

Class I - Dangerous

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Dec 28, 2023 Other Drugs Nationwide View Details →

VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.

Denver Solutions, LLC

Class I - Dangerous

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Dec 28, 2023 Other Drugs Nationwide View Details →

FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.

Denver Solutions, LLC

Class I - Dangerous

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Dec 28, 2023 Other Drugs Nationwide View Details →

PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.

Denver Solutions, LLC

Class I - Dangerous

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Dec 28, 2023 Other Drugs Nationwide View Details →

PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.

Denver Solutions, LLC

Class I - Dangerous

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Dec 28, 2023 Other Drugs Nationwide View Details →

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