CLASS II Drug recall · Reported 3 Sep 2014 · FDA Enforcement Report
Glycopyrrolate 0.2 mg/ml pre-filled syringe recalled
Pharmakon Pharmaceuticals is recalling Glycopyrrolate 0.2 mg/ml pre-filled syringe, distributed in Illinois, Indiana, Maryland, Texas. The recall was initiated on 21 Apr 2014 and the FDA has classified it as Class II.
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-1567-2014
- FDA event ID
- 68191
- Recalling firm
- Pharmakon Pharmaceuticals, Noblesville, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Apr 2014
- FDA classified
- 26 Aug 2014
- Reported
- 3 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
Timeline
| 21 Apr 2014 | Recall initiated by company | |
| 26 Aug 2014 | Classified by FDA | +127 days |
| 3 Sep 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Product as listed by the FDA
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.
Where it was distributed
United States: TX, IL, MD, IN
Questions about this recall
Why was it recalled?
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Which lots are affected?
Lot #: E131210.212 Exp: 07/14/2014
Where was it sold?
United States: TX, IL, MD, IN
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
3 other products · FDA event 68191| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in PVC Vial recalled | Pharmakon Pharmaceuticals | Labeling Errors | 4 states | |
| CLASS I | Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in and IV recalled | Pharmakon Pharmaceuticals | Labeling Errors | 4 states | |
| CLASS I | Atropine Sulfate 0.4 mg/ml Injection recalled | Pharmakon Pharmaceuticals | Labeling Errors | 4 states |
More recalls from Pharmakon Pharmaceuticals
All 116| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Succinylcholine Chloride 20 mg/mL BD syringe recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ketamine 20 mg/mL in 0.9% Sodium Chloride lntravia recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride fill recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ketamine 50mg/mL in 0.9% Sodium Chloride fill in syringe recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Cefazolin 2GM added to 5% Dextrose recalled by Pharmakon Pharmaceuticals | Pharmakon Pharmaceuticals | Sterility | Nationwide |
Other Glycopyrrolate recalls
All 43| 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 (0.2 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 II | Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | glycopyrrolate 1 mg/ (0.2 mg/mL), For Anesthesia Use, Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |