Recalls / Class II
Class IID-0791-2016
Product
Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35
- Affected lot / code info
- Lot #: 020316 and 011216
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Walter's Pharmacy
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 401 N 17th St, N/A, Allentown, Pennsylvania 18104-5034
Distribution
- Quantity
- 2 bottles
- Distribution pattern
- PA
Timeline
- Recall initiated
- 2016-02-12
- FDA classified
- 2016-03-29
- Posted by FDA
- 2016-04-06
- Terminated
- 2017-01-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0791-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.