Why it was recalled
Stability data does not support expiry.
Product description
Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Lot numbers, UPCs & expiration codes
All lots with expiration dates up to 11/17/2015
Where it was sold
Nationwide
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-0590-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 19, 2015
- FDA report date
- Feb 3, 2016
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmakon Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0590-2016, exactly as published.
Show all FDA fields
- City
- Noblesville
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 72177
- Address
- 14450 Getz Rd
- Code information
- All lots with expiration dates up to 11/17/2015
- Postal code
- 46060-3303
- Report date
- Feb 3, 2016
- Product type
- Drugs
- Recall number
- D-0590-2016
- Classification
- Class II
- Recalling firm
- Pharmakon Pharmaceuticals
- Termination date
- May 9, 2017
- Reason for recall
- Stability data does not support expiry.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 19, 2015
- Initial firm notification
- Telephone
- Center classification date
- Jan 27, 2016