FDA (Drugs) recall action 89042

Dr. Reddy's Laboratories, Inc. recalled 9 products on 2021-12-15

The FDA (Drugs) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2021-12-15
Critical: 0
Units: 44,832

Why these products were recalled

Failed dissolution specifications

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–9 of 9

LowFDA (Drugs)··2021-12-15
CVS Allergy & Congestion Relief Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling CVS Allergy & Congestion Relief tablets (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg extended-release) nationwide due to failed dissolution specifications.
Product
Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
Category
Distribution
0 states
LowFDA (Drugs)··2021-12-15
CVS Allergy Relief D Extended-Release Tablets Recall
CVS Allergy Relief D extended-release tablets (Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg) are being recalled because they failed dissolution specifications, meaning the tablets may not release the medication properly.
Product
Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30
Category
Distribution
0 states
ModerateFDA (Drugs)··2021-12-15
OTC Allergy and Congestion Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling 5,016 cartons of Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg Extended Release Tablets nationwide due to failed dissolution specifications. Affected lot is AC2103329F with expiration 1/2023.
Product
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
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Distribution
0 states
LowFDA (Drugs)··2021-12-15
Fexofenadine and Pseudoephedrine allergy relief tablets recalled for failed dissolution
Dr. Reddy's Laboratories is recalling a 12 HR Allergy & Congestion Relief product distributed nationwide because the tablets failed to meet dissolution specifications, which may affect drug effectiveness.
Product
12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.
Category
Distribution
0 states
ModerateFDA (Drugs)··2021-12-15
Antihistamine and Decongestant Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets distributed by Rugby Laboratories due to failed dissolution specifications. Affected lot AC2103329D (Exp 1/2023) was distributed nationwide in 2,184 cartons.
Product
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.
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Distribution
0 states
ModerateFDA (Drugs)··2021-12-15
Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended Release Tablets because they failed dissolution specifications, which may affect how the medication works in the body.
Product
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.
Category
Distribution
0 states
ModerateFDA (Drugs)··2021-12-15
Allergy and Congestion tablets recalled due to failed dissolution specifications
Dr. Reddy's Laboratories is recalling Allergy and Congestion (Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg) Extended-Release Tablets because they failed to meet dissolution specifications. Approximately 4,896 cartons distributed nationwide are affected.
Product
ALLERGY AND CONGESTION (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Category
Distribution
0 states
LowFDA (Drugs)··2021-12-15
Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets because they failed to meet dissolution specifications, which may affect how the medication works in the body.
Product
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Category
Distribution
0 states
ModerateFDA (Drugs)··2021-12-15
Walmart Allergy Relief D Extended-Release Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Walmart brand Allergy Relief D extended-release tablets (Lot #AC2103329B) nationwide because the tablets failed to meet dissolution specifications, which may affect medication effectiveness.
Product
Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.
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0 states