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Allergy & Cold Medication Recalls

Recalls of antihistamines, decongestants and nasal sprays.

320 recalls in this category, newest first.

Class II · Moderate risk Ongoing Apr 26, 2023

Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0832-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0804-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0787-2023

Class II · Moderate risk Completed Apr 26, 2023

Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7…

Reason Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.

Apotex Corp. NDC 60505-0823-6 D-0568-2023

Class II · Moderate risk Terminated Mar 2, 2023

Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL…

Reason Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low…

Endo Pharmaceuticals, Inc. NDC 49884-161-11 D-0475-2023

Class II · Moderate risk Ongoing Feb 23, 2023

NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions…

Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation D-0438-2023

Class II · Moderate risk Ongoing Feb 23, 2023

NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp…

Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation D-0437-2023

Class II · Moderate risk Ongoing Feb 14, 2023

Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7…

Reason CGMP Deviations

Pharmedica USA, LLC D-0457-2023

Class II · Moderate risk Terminated Feb 9, 2023

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 36800-691-39 D-0912-2023

Class II · Moderate risk Terminated Feb 9, 2023

Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company D-0911-2023

Class II · Moderate risk Terminated Feb 9, 2023

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 11673-617-22 D-0910-2023

Class II · Moderate risk Terminated Feb 9, 2023

allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 56062-847-39 D-0909-2023

Class II · Moderate risk Terminated Feb 9, 2023

Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 0113-0847-39 D-0908-2023

Class II · Moderate risk Terminated Feb 9, 2023

Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 45802-847-78 D-0907-2023

Class II · Moderate risk Terminated Feb 9, 2023

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 79481-0847-0 D-0906-2023

Class II · Moderate risk Terminated Feb 9, 2023

Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 63981-847-48 D-0905-2023

Class II · Moderate risk Terminated Feb 9, 2023

aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Perrigo…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 55301-847-39 D-0904-2023

Class II · Moderate risk Terminated Feb 9, 2023

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 69842-0914-39 D-0903-2023

Class II · Moderate risk Terminated Feb 9, 2023

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 72476-847-22 D-0902-2023

Class II · Moderate risk Terminated Feb 9, 2023

Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 68391-847-47 D-0901-2023

Class II · Moderate risk Terminated Feb 9, 2023

Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 72288-847-39 D-0900-2023

Class II · Moderate risk Terminated Dec 27, 2022

Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy…

Reason Lack of sterility assurance

Sentara Infusion Services D-0289-2023

Class III · Low risk Terminated Nov 21, 2022

Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets…

Reason Failed dissolution specifications

Dr. Reddy's Laboratories, Inc. NDC 49032-273-20 D-0073-2023

Class II · Moderate risk Ongoing Jun 23, 2022

READY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRAPE 4 FL OZ SKU 999368 GOOD SENSE ALLERGY CETIRIZINE…

Reason CGMP Deviations: product held outside appropriate storage temperature conditions.

Family Dollar Stores, Llc. D-1452-2022

Class II · Moderate risk Ongoing Jun 23, 2022

CLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG TABLETS 5 CT SKU 916116 GS ALLERGY LORATADINE…

Reason CGMP Deviations: product held outside appropriate storage temperature conditions.

Family Dollar Stores, Llc. D-1451-2022