Why it was recalled
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: E0333282R; Exp: 7/13/2014
Where it was sold
United States: TX, IL, MD, IN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1568-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 21, 2014
- FDA report date
- Sep 3, 2014
- Quantity
- 5 Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmakon Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1568-2014, exactly as published.
Show all FDA fields
- City
- Noblesville
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 68191
- Address
- 14450 Getz Rd
- Code information
- Lot #: E0333282R; Exp: 7/13/2014
- Postal code
- 46060-3303
- Report date
- Sep 3, 2014
- Product type
- Drugs
- Recall number
- D-1568-2014
- Classification
- Class I
- Recalling firm
- Pharmakon Pharmaceuticals
- Product quantity
- 5 Syringes
- Termination date
- Dec 3, 2014
- Reason for recall
- Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- United States: TX, IL, MD, IN
- Recall initiation date
- Apr 21, 2014
- Initial firm notification
- Telephone
- Center classification date
- Aug 26, 2014