CLASS I Drug recall · Reported 14 Jul 2021 · FDA Enforcement Report
Topotecan Injection 4 mg/ (1 mg/mL), Single-Dose vial recalled
Teva Pharmaceuticals USA is recalling Topotecan Injection 4 mg/ (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc, distributed nationwide in the US. The recall was initiated on 18 Jun 2021 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0661-2021
- FDA event ID
- 88154
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Jun 2021
- FDA classified
- 15 Jul 2021
- Reported
- 14 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Jun 2021 | Recall initiated by company | |
| 14 Jul 2021 | Published in enforcement report | +26 days |
| 15 Jul 2021 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Product as listed by the FDA
Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Which lots are affected?
Lot # 31328962B, exp. date 04/2022
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets recalledMetoclopramide | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Topotecan recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Topotecan 1.24 MG / Ns Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |