Dr Reddy's Laboratories Limited recalls Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam -…
- Recall date
- June 21, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0923-2023
- FDA classification
- Class II
- Brand / firm
- Dr Reddy's Laboratories Limited
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
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