CLASS III Drug recall · Reported 26 Feb 2020 · FDA Enforcement Report
Glycopyrrolate Injection, USP 4 mg per 2 mg/mL) Multiple Dose Vial recalled
AuroMedics Pharma is recalling Glycopyrrolate Injection, USP 4 mg per 2 mg/mL) Multiple Dose Vial, distributed in Louisiana, Mississippi, Ohio. The recall was initiated on 7 Feb 2020 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-0853-2020
- FDA event ID
- 84927
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Brand
- Glycopyrrolate
- Manufacturer
- AuroMedics Pharma LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Feb 2020
- FDA classified
- 20 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 7 Feb 2020 | Recall initiated by company | |
| 20 Feb 2020 | Classified by FDA | +13 days |
| 26 Feb 2020 | 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
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
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
Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20.
Where it was distributed
Ohio, Louisiana, Mississippi
Questions about this recall
Is Glycopyrrolate Injection, USP 4 mg per 2 mg/mL) Multiple Dose Vial recalled?
Yes. AuroMedics Pharma recalled Glycopyrrolate Injection, USP 4 mg per 2 mg/mL) Multiple Dose Vial on 7 Feb 2020. The recall is Class III and its status is Terminated. Recall number D-0853-2020.
Why was it recalled?
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Which lots are affected?
Lot #CGP190001-A, Exp. 07/31/2020
Where was it sold?
Ohio, Louisiana, Mississippi
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 21 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 AuroMedics Pharma
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fondaparinux Sodium Injection, USP, 5 mg per, Single Dose recalledFondaparinux Sodium | AuroMedics Pharma | Potency & Assay | Nationwide |
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| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Polymyxin B for Injection USP per Vial vials recalledPolymyxin B | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen | AuroMedics Pharma | Other | Nationwide |
Other Glycopyrrolate recalls
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycopyrrolate Oral Solution, 1 mg/, delivers recalled by Precision DoseGlycopyrrolate | Precision Dose | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per 2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Glycopyrrolate Oral Solution, 1 mg recalled by Novadoz PharmaceuticalsGlycopyrrolate | Novadoz Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate | Aurolife Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Glycopyrrolate Injection, USP 2mg/ML Vial recalled by HF Acquisition CoGlycopyrrolate | HF Acquisition Co | Packaging Defects | AZ, CA, TX |