Allergy & Cold Medication Recalls

Recalls of antihistamines, decongestants and nasal sprays.

320 recalls in this category, newest first.

Class II · Moderate risk Terminated Oct 26, 2021

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle…

Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Perrigo Company PLC D-0604-2022

Class II · Moderate risk Terminated Oct 26, 2021

Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle…

Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Perrigo Company PLC D-0603-2022

Class III · Low risk Terminated Oct 12, 2021

AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs…

Reason Failed Moisture Limits

Sun Pharmaceutical Industries INC NDC 63981-724-15 D-0069-2022

Class III · Low risk Terminated Oct 12, 2021

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg)…

Reason Failed Moisture Limits

Sun Pharmaceutical Industries INC NDC 0904-5833-15 D-0068-2022

Class III · Low risk Terminated Oct 5, 2021

Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg…

Reason Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count…

A-S Medication Solutions LLC. D-0096-2022

Class II · Moderate risk Terminated Sep 22, 2021

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva…

Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Teva Pharmaceuticals USA NDC 59310-136-06 D-0025-2022

Class II · Moderate risk Terminated Sep 22, 2021

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva…

Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Teva Pharmaceuticals USA NDC 59310-129-06 D-0024-2022

Class II · Moderate risk Terminated Sep 22, 2021

AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva…

Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Teva Pharmaceuticals USA NDC 59310-111-06 D-0023-2022

Class II · Moderate risk Terminated Sep 22, 2021

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only…

Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Teva Pharmaceuticals USA NDC 59310-530-08 D-0022-2022

Class II · Moderate risk Terminated Sep 22, 2021

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only…

Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Teva Pharmaceuticals USA NDC 59310-520-08 D-0021-2022

Class II · Moderate risk Terminated Aug 3, 2021

Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park…

Reason Failed Impurities/Degradation Specifications

The Harvard Drug Group NDC 0904-6979-40 D-0289-2022

Class II · Moderate risk Terminated Jul 27, 2021