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

  • Recalled Dr. Reddy’s Imatinib Mesylate Tablets 100 mg
  • Recalled Dr. Reddy’s Imatinib Mesylate Tablets 100 mg
  • Recalled Dr. Reddy’s Imatinib Mesylate Tablets 400 mg
  • Recalled Dr. Reddy’s Imatinib Mesylate Tablets 400 mg
  • Recalled Dr. Reddy’s Pregabalin Capsules 50 mg
  • Recalled Dr. Reddy’s Pregabalin Capsules 50 mg
  • Recalled Dr. Reddy’s Pregabalin Capsules 75 mg
  • Recalled Dr. Reddy’s Pregabalin Capsules 75 mg
  • Recalled Dr. Reddy’s Pregabalin Capsules 100 mg
  • Recalled Dr. Reddy’s Pregabalin Capsules 100 mg
  • Recalled Dr. Reddy’s Pregabalin Capsules 150 mg
  • Recalled Dr. Reddy’s Sevelamer Carbonate Tablets 800 mg
  • Recalled Dr. Reddy’s Sevelamer Carbonate Tablets 800 mg
  • Recalled Dr. Reddy’s Tadalafil Tablets 5 mg
  • Recalled Dr. Reddy’s Tadalafil Tablets 5 mg
  • Recalled Dr. Reddy’s Tadalafil Tablets 20 mg
  • Recalled Dr. Reddy’s Tadalafil Tablets 20 mg
Name of Product:
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
Recall Date:
February 25, 2021
Units:

About 21,400

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

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

 

Remedy:

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.

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

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

Manufactured In:
India
Recall number:
21-089

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The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risk of injury associated with the use of thousands of types of consumer products. Deaths, injuries, and property damage from consumer product-related incidents cost the nation more than $1 trillion annually. Since the CPSC was established more than 50 years ago, it has worked to ensure the safety of consumer products, which has contributed to a decline in injuries associated with these products.

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