CLASS III Drug recall · Reported 27 Dec 2017 · FDA Enforcement Report
Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 5% Dextrose recalled
Claris Lifesciences is recalling Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 5% Dextrose, distributed nationwide in the US. The recall was initiated on 6 Nov 2017 and the FDA has classified it as Class III.
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-0127-2018
- FDA event ID
- 78446
- Recalling firm
- Claris Lifesciences, North Brunswick, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Nov 2017
- FDA classified
- 21 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 6 Nov 2017 | Recall initiated by company | |
| 21 Dec 2017 | Classified by FDA | +45 days |
| 27 Dec 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Superpotent
Which lots are affected?
A060192 01/2018; A060305 02/2018; A061038 08/2018; A0A0068 12/2018; A0A0404 04/2019
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Claris Lifesciences
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metronidazole Injection, USP, 500 mg recalled by Claris Lifesciences | Claris Lifesciences | Sterility | Nationwide |
| Drug | CLASS II | Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 5% Dextrose recalled | Claris Lifesciences | Sterility | Nationwide |
| Drug | CLASS II | Levofloxacin Injection in 5% Dextrose, 750 mg in 5% Dextrose recalledLevofloxacin | Claris Lifesciences | Sterility | Nationwide |
| Drug | CLASS II | Fluconazole Injection, USP, 400 mg recalled by Claris Lifesciences | Claris Lifesciences | Sterility | Nationwide |
Other Ciprofloxacin recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package recalledCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin ophthalmic solution USP, 0.3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl) recalled | Akorn | Manufacturing (CGMP) Deviations | Nationwide |