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
Reported: July 26, 2023 Initiated: June 21, 2023 #D-0923-2023
Product Description
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
Reason for Recall
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Details
- Recalling Firm
- Dr Reddy's Laboratories Limited
- Units Affected
- 17,548 1000-countbottles
- Distribution
- Nationwide in the USA
- Location
- Ranasthalam Mandal, Srikakulam, N/A
Frequently Asked Questions
What product 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. Recalled by Dr Reddy's Laboratories Limited. Units affected: 17,548 1000-countbottles.
Why was this product recalled? ▼
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 26, 2023. Severity: Moderate. Recall number: D-0923-2023.
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