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
Reported: June 25, 2014 Initiated: May 12, 2014 #D-1394-2014
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Details
- Recalling Firm
- John W Hollis Inc
- Units Affected
- 2250 mL
- Distribution
- Nationwide
- Location
- Nashville, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by John W Hollis Inc. Units affected: 2250 mL.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 25, 2014. Severity: Moderate. Recall number: D-1394-2014.
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