Recalls / Class II
Class IID-0793-2016
Product
Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09
- Affected lot / code info
- Lot #: 112015, 112715, 113015,120515, 120715, 121215, 121515, 122115, 010516, 010716, 010816, 011116, 012016, 012816, 012916, 020316, 020416, 020516.
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
- 22 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-0793-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.