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FDA Drug Recalls

1,122 recalls, newest first

Class III · Low risk Terminated Feb 1, 2023

Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc D-0351-2023

Class III · Low risk Terminated Feb 1, 2023

Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc D-0350-2023

Class III · Low risk Terminated Feb 1, 2023

Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc D-0349-2023

Class II · Moderate risk Terminated Jan 31, 2023

Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ…

Reason Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.

Biocon Pharma INC NDC 70377-038-11 D-0268-2023

Class II · Moderate risk Ongoing Jan 30, 2023

Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml)…

Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the…

Global Pharma Healthcare Private Limited D-0922-2023

Class I · High risk Ongoing Jan 30, 2023

Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml)…

Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Global Pharma Healthcare Private Limited D-0921-2023

Class II · Moderate risk Ongoing Jan 30, 2023

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by…

Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the…

Global Pharma Healthcare Private Limited NDC 79503-0101-15 D-0920-2023

Class I · High risk Ongoing Jan 30, 2023

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by…

Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Global Pharma Healthcare Private Limited NDC 79503-0101-15 D-0919-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0160-5 D-0345-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0150-5 D-0344-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0145-5 D-0343-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0135-5 D-0342-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0125-5 D-0341-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0120-5 D-0340-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0117-5 D-0339-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0115-5 D-0338-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0113-5 D-0337-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0112-5 D-0336-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0110-5 D-0335-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0155-5 D-0334-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0140-5 D-0333-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0130-5 D-0332-2023

Class II · Moderate risk Terminated Jan 30, 2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…

Reason Subpotent Drug

Ibsa Pharma INC NDC 71858-0105-5 D-0331-2023

Class III · Low risk Ongoing Jan 30, 2023

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by…

Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

Akorn, Inc. D-0265-2023

Class II · Moderate risk Terminated Jan 27, 2023

Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by…

Reason Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.

Amerisource Health Services LLC D-0436-2023