News From CPSC: Dr. Reddy’s Recalls Prescription Drug Blister Packages Due to Risk of Poisoning Announced February 25, 2021
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1. Dr. Reddy’s Recalls Prescription Drug Blister Packages Due to Risk of Poisoning: https://www.cpsc.gov/Recalls/2021/Dr-Reddys-Recalls-Prescription-Drug-Blister-Packages-Due-to-Risk-of-Poisoning
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1. Dr. Reddy’s Recalls Prescription Drug Blister Packages Due to Risk of Poisoning:
Recall Date: February 25, 2021
Recall Number: 21-089
Recall Summary
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
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.
Pictures available here:
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:
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
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The U.S. Consumer Product Safety Commission (CPSC) is still interested in receiving incident or injury reports that are either directly related to a product recall or involve a different hazard with the same product. Please tell us about your experience with the product on SaferProducts.gov.
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