Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 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-1388-2014
Product Description
Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 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
- 300 mL
- Distribution
- Nationwide
- Location
- Nashville, TN
Frequently Asked Questions
What product was recalled? ▼
Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234. Recalled by John W Hollis Inc. Units affected: 300 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-1388-2014.
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