Recalls / Class II
Class IID-1542-2016
Product
Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
- Affected lot / code info
- Lot# 397267, Use by 9/20/16
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 115 S 40th Ave, N/A, Hattiesburg, Mississippi 39402-6600
Distribution
- Quantity
- 6 vials
- Distribution pattern
- MS
Timeline
- Recall initiated
- 2016-07-26
- FDA classified
- 2016-09-27
- Posted by FDA
- 2016-10-05
- Terminated
- 2016-11-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1542-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.