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

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 Tabl

Date of Recall

2021-02-25

CPSC Release Number

21-089

Manufactured In

India

Units

About 21,400

Importer

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

Sold By

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.

Problem/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.

Injuries/Incidents

No incidents or injuries have been reported.

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

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.

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