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Imatinib Mesylate Tablets 100 mg, Imatinib Mesylate Tablets 400 mg, Pregabalin Capsules 50 mg, Pr...

CPSC Recall #21-089 — February 25, 2021

Recall Summary

Recall Number21-089
Recall DateFebruary 25, 2021
Remedy TypeRefund
Units AffectedAbout 21,400
ManufacturerDr. Reddy’s Laboratories, Ltd., of India
ImporterDr. Reddy’s Laboratories, Inc., of Princeton, N.J.
Manufactured InIndia

Where It Was Sold

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.

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

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  

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.

Incidents & Injuries

No incidents or injuries have been reported.

Remedy Instructions

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.

What Should You Do?

Stop using this product immediately. Contact the manufacturer for a Refund at no charge. If you experienced an injury, report it at SaferProducts.gov.

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Frequently Asked Questions

Follow the consumer action instructions in the recall notice above. Most recalls require you to stop using the product and contact the manufacturer directly — either by calling the toll-free number listed in the official CPSC notice or by visiting the manufacturer's website. You generally do not need a receipt or original packaging to claim a remedy. The manufacturer is legally required to provide the remedy (Refund) at no cost to you.

Yes. If you were injured by a defective consumer product — whether recalled or not — you may have grounds for a product liability claim against the manufacturer and potentially the retailer. A recall notice can serve as evidence that the manufacturer was aware of the defect. Injuries that may support a claim include burns, lacerations, fractures, electric shock, choking incidents, and chemical exposure. Most product liability attorneys work on a contingency fee basis, meaning you pay nothing unless you win. Consult an attorney promptly, as statutes of limitation vary by state.

In most cases, no. CPSC-coordinated recall remedies are designed to be accessible without proof of purchase. Manufacturers typically ask consumers to self-certify ownership and may ask for photos of the product or its serial number. Some manufacturers request that you mail in a portion of the product (such as a cut cord or removed component) as proof of disposal. Check the specific remedy instructions for this recall for exact requirements. If you registered your product at the time of purchase, the process is usually even simpler.

If the original manufacturer has gone out of business, the recall remedy may no longer be available through them. In this case, contact CPSC directly at 1-800-638-2772 or cpsc.gov for guidance. If the brand was acquired by another company, the acquiring company may have assumed recall obligations. In some cases where a remedy is unavailable, CPSC advises consumers to safely dispose of the product. If you were injured by the product of a defunct company, consult a product liability attorney — parent companies, distributors, and retailers may still bear liability in some circumstances.

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