CLASS I Drug recall · Reported 3 Sep 2014 · FDA Enforcement Report
Atropine Sulfate 0.4 mg/ml Injection recalled
Pharmakon Pharmaceuticals is recalling Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 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 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-1568-2014
- FDA event ID
- 68191
- Recalling firm
- Pharmakon Pharmaceuticals, Noblesville, IN
- Classification
- Class I
- 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
- Drug class
- Injectable & IV Drugs
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
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
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 #: E0333282R; Exp: 7/13/2014
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 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.
Other products in this recall event
3 other products · FDA event 68191This product is part of a recall event; the main page for the event is Glycopyrrolate 0.2 mg/ml pre-filled syringe recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Glycopyrrolate 0.2 mg/ml pre-filled syringe recalled | Pharmakon Pharmaceuticals | Labeling Errors | 4 states | |
| 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 |
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 Atropine recalls
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Atropine Sulfate injection, USP, 1 mg/mL recalled by American RegentAtropine Sulfate | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS III | Atropine Sulfate Ophthalmic Solution recalled by Somerset TherapeuticsAtropine Sulfate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS I | Atropine Sulfate Injection, USP 1 mg/ (0.1 mg/mL) recalled by PfizerAtropine Sulfate | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Atropine Sulfate Injection, USP 8 mg recalled by Accord HealthcareAtropine Sulfate | Accord Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Atropine Sulfate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |