Supply Chain Council of European Union | Scceu.org
Distribution

Dr. Reddy’s Recalls Prescription Drug Blister Packages Due to Risk of Poisoning | News

WASHINGTON, Feb. 25, 2021 /PRNewswire/ — https://cpsc.gov/Recalls/2021/Dr-Reddys-Recalls-Prescription-Drug-Blister-Packages-Due-to-Risk-of-Poisoning

Recall Summary

Name of Products: Imatinib Mesylate Tablets 100 mg, Imatinib Mesylate Tablets 400 mg, Pregabalin Capsules 50 mg, Pregabalin Capsules 75 mg, Pregabalin Capsules 100 mg, Pregabalin Capsules 150 mg, Sevelamer Carbonate Tablets 800 mg, Tadalafil Tablets 5 mg and Tadalafil Tablets 20 mg

Hazard: The products are prescription medications that were labeled and distributed by Dr. Reddy’s for institutional use only.  The prescription medications were distributed by third party wholesalers to retail pharmacies and could have been dispensed to consumers.  The packaging of the products is not child resistant and can pose a risk of poisoning if the contents are swallowed by young children.

Remedy: Refund

Consumers should immediately store the recalled medications in a safe location out of reach of children and contact Dr. Reddy’s for a full refund.

Consumer Contact:

Dr. Reddy’s toll-free at 888-375-3784 from 8 a.m. to 8 p.m. ET Monday through Friday, or online at www.drreddys.com and click on “Recall” for more information.  Report incidents related to children accessing or ingesting these prescription medications to www.SaferProducts.gov.  Report adverse events, medication errors, and quality problems related to the use of these products to FDA’s MedWatch Adverse Event Reporting Program either online at www.fda.gov/medwatch/report.htm, download the form at www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and submit by regular mail, and return to the address on the pre-addressed form, or submit by fax to 800-FDA-0178.

Recall Details

Units: About 21,400

Description:

This recall involves blister packages of prescription medications.  The name and strength of the medication, “For Institutional Use only,” “Rx Only,” lot number and expiration date are printed on the outside of the package as well as on the individual blister units.  The Dr. Reddy’s logo and NDC number are printed on the outside of the package.  The recalled medications include the following:

Recalled

Prescription

Drugs

NDC Numbers

Carton

Configurations

Lot Numbers

Expiration

Dates

Imatinib

Mesylate Tablets

100 mg

43598-344-31

 

3 blister cards of

10 tablets

 

H2000138

 

2022-0630

Imatinib

Mesylate Tablets

400 mg

43598-345-31

3 blister cards of

10 tablets

H2000127

2022-0630

Pregabalin

Capsules 50 mg

43598-292-66

5 blister cards of

10 capsules

T900876

2021-0630

Pregabalin

Capsules 75 mg

43598-293-66

5 blister cards of

10 capsules

T901021

2021-0731

Pregabalin

Capsules 100 mg

43598-294-66

5 blister cards of

10 capsules

T901022

2021-0731

Pregabalin

Capsules 150 mg

43598-295-66

5 blister cards of

10 capsules

T901023

2021-0731

Sevelamer

Carbonate

Tablets 800 mg

55111-789-11

4 blister cards of

25 tablets

T801003,

T000009,

T900221

2020-1031,

2021-1231,

2021-0228

Tadalafil

Tablets 5 mg

43598-575-31

3 blister cards of

10 tablets

T000376

2022-0131

Tadalafil

Tablets 20 mg

43598-573-31

3 blister cards of

10 tablets

T000425

2022-0228

Incidents/Injuries: No incidents or injuries have been reported.

Sold At: Beginning in 2018, Dr. Reddy’s sold the recalled medications to wholesalers.  Ultimately, these medications could have been sold to consumers at retail pharmacies in the United States at prices varying based on quantities prescribed, health insurance terms, and other factors.

Importer: Dr. Reddy’s Laboratories, Inc., of Princeton, N.J.

Manufacturer: Dr. Reddy’s Laboratories, Ltd., of India

Manufactured in: India

Footer

About the U.S. CPSC

The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products.  Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually.  CPSC’s work to ensure the safety of consumer products has contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 40 years.

Federal law bars any person from selling products subject to a publicly announced voluntary recall by a manufacturer or a mandatory recall ordered by the Commission.

For lifesaving information:

– Visit CPSC.gov.

– Sign up to receive our e-mail alerts.

– Follow us on Facebook, Instagram @USCPSC and Twitter @USCPSC

– Report a dangerous product or a product-related injury on www.SaferProducts.gov.

– Call CPSC’s Hotline at 800-638-2772 (TTY 301-595-7054).

– Contact a media specialist

Note:  Due to the extraordinary circumstances surrounding COVID-19, some of the remedies identified in recall press releases may not be available at this time.  Consumers should check with recalling firms for further details.  It is important to remember that CPSC and recalling firms urge consumers not to use recalled products.

Release Number: 21-089

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dr-reddys-recalls-prescription-drug-blister-packages-due-to-risk-of-poisoning-301236115.html

SOURCE U.S. Consumer Product Safety Commission

Related posts

Health authorities warn onions tainted with salmonella are making people sick in Utah – St George News

scceu

Navigating Qualified Charitable Distributions – TAPinto.net

scceu

Woodland Hills School District Holds Desk Distribution Event – CBS Pittsburgh

scceu
`