Recalls / Class II
Class IID-1394-2014
Product
Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
- Affected lot / code info
- Lot 1507, Use by 5/18/14; Lot 1863, Use by 7/20/14
Why it was recalled
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recalling firm
- Firm
- John W Hollis Inc
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 110 20th Ave N, N/A, Nashville, Tennessee 37203-2315
Distribution
- Quantity
- 2250 mL
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-12
- FDA classified
- 2014-06-18
- Posted by FDA
- 2014-06-25
- Terminated
- 2014-07-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1394-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.