Class III · Low risk
Argatroban Injection
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
Affected NDCs
0703-0020-31
0703-0020-32
Compare with the code on your package — it is the most precise check available.
Drug: Argatroban
- Recalling firm
- Teva North America
- NDC code
- 0703-0020-31
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1494-2016 · 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 Argatroban recalls
See all
Class III · Low risk
Argatroban Injection
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Class I · High risk
Argatroban Injection 50 mg per 50ml
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Other recalls by Teva North America
All 2016 recalls
Class III · Low risk
Claravis (isotretinoin capsules USP)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Children's Qnasl 40 mcg
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Superpotent drug: Out of specification test result for assay during stability testing.
Class II · Moderate risk
Albuterol Sulfate Syrup
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
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