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.
About 21,400
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.
Detalles del retiro
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 |
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.
No incidents or injuries have been reported.
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.
Dr. Reddy’s Laboratories, Ltd., of India
Dr. Reddy’s Laboratories, Inc., of Princeton, N.J.
Related Recalls
La Comisión de Seguridad de Productos del Consumidor de EE.UU. (U.S. Consumer Product Safety Commission, CPSC) se encarga de proteger al público contra riesgos irrazonables de lesión o muerte asociados con el uso de miles de tipos de productos del consumidor. Muertes, lesiones y daños a la propiedad debido a incidentes con productos del consumidor le cuestan al país más de $1 billón de dólares al año. La labor de la CPSC ha contribuido a una disminución en el índice de muertes y lesiones vinculadas a los productos del consumidor en los últimos 40 años.
Para más información:
- Visite SeguridadConsumidor.gov.
- Reciba alertas electrónicas.
- Síganos en Twitter @SeguridadConsum, @USCPSC y en Facebook e Instagram @USCPSC.
- Reporte productos peligrosos o lesiones por productos en www.SaferProducts.gov.
- Llame a la línea de información al 800-638-2772 (teletipo 301-595-7054).
- Contacto para los medios de comunicación.
Por favor comuníquese con la CPSC si desea información al:
Teléfono: (301) 504-7908
En español: (301) 504-7800