Why it was recalled
Lack of Assurance of Sterility
Product description
Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54
Lot numbers, UPCs & expiration codes
Lot #: 020216
Where it was sold
PA
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-0797-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 12, 2016
- FDA report date
- Apr 6, 2016
- Quantity
- 1 bottle
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Walter's Pharmacy
Original FDA data
Every field from FDA enforcement report D-0797-2016, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 73336
- Address
- 401 N 17th St
- Code information
- Lot #: 020216
- Postal code
- 18104-5034
- Report date
- Apr 6, 2016
- Product type
- Drugs
- Recall number
- D-0797-2016
- Classification
- Class II
- Recalling firm
- Walter's Pharmacy
- Product quantity
- 1 bottle
- Termination date
- Jan 6, 2017
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54
- Distribution pattern
- PA
- Recall initiation date
- Feb 12, 2016
- Initial firm notification
- Telephone
- Center classification date
- Mar 29, 2016