Class II · Moderate risk
Tizanidine Tablets
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Tizanidine Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.
Affected NDC
68084-0645-01
Compare with the code on your package — it is the most precise check available.
Drug: Tizanidine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tizanidine NDC 68084-0645 |
HYDROCHLORIDE 4 mg/1 | Tablet Oral |
American Health Packaging | Rx |
- Recalling firm
- Amerisource Health Services LLC
- NDC code
- 68084-645-01
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0892-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tizanidine recalls
See all
Class II · Moderate risk
Tizanidine Hydrochloride Tablet 4mg
Failed Stability Specifications
Class II · Moderate risk
Tizanidine Tablets USP
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Class II · Moderate risk
Tizanidine HCl Tablets
Failed Tablet/Capsule Specification: Some tablets are shaved
Class II · Moderate risk
Tizanidine Tablets
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Other recalls by Amerisource Health Services LLC
All 2023 recalls
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class II · Moderate risk
Meclizine Hydrochloride Tablets
Failed tablet specifications.
Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
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