FDAClass ISeptember 3, 2014

Atropine Sulfate 0.4 mg/ml Injection recall

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…

Why was Atropine Sulfate 0.4 mg/ml Injection recalled?

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: E0333282R; Exp: 7/13/2014

Product
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…
Recalling firm
Pharmakon Pharmaceuticals
Quantity
5 Syringes
Distribution
United States: TX, IL, MD, IN
Recall date
September 3, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls