Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Bivalirudin for Injection 250 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: Particulate matter identified as fiber.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.
Affected NDC
16729-0275-67
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Bivalirudin NDC 16729-0275 |
250 mg/5mL | Injection, Powder, Lyophilized, for Solution Intravenous |
Accord Healthcare, Inc. | Rx |
- Recalling firm
- Accord Healthcare, Inc.
- NDC code
- 16729-275-67
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0918-2023 · 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 recalls by Accord Healthcare, Inc.
All 2023 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Other particulate / foreign matter recalls from 2023
All particulate / foreign matter recalls
Class II · Moderate risk
Ibuprofen and Famotidine Tablets 800mg/26.6mg
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class II · Moderate risk
buPROPion Hydrochloride Extended-Release Tablets
Presence of Foreign Tablets/Capsules
Class I · High risk
Bleomycin for Injection
Presence of particulate matter: glass
Class I · High risk
Atropine Sulfate Injection
Presence of Particulate Matter; identified as glass
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