Why it was recalled
Lack of Assurance of Sterility
Product description
Phenylephrine 500mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Lot numbers, UPCs & expiration codes
all lots
Where it was sold
Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah
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-0441-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 19, 2015
- FDA report date
- Dec 9, 2015
- Quantity
- 1 container
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Western Drug
Original FDA data
Every field from FDA enforcement report D-0441-2016, exactly as published.
Show all FDA fields
- City
- Springerville
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 72520
- Address
- 105 W Main St
- Code information
- all lots
- Postal code
- 85938-7203
- Report date
- Dec 9, 2015
- Product type
- Drugs
- Recall number
- D-0441-2016
- Classification
- Class II
- Recalling firm
- Western Drug
- Product quantity
- 1 container
- Termination date
- Oct 1, 2016
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine 500mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Distribution pattern
- Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah
- Recall initiation date
- Oct 19, 2015
- Initial firm notification
- Telephone
- Center classification date
- Dec 1, 2015