Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 Avenue N, Nashville, TN 37203, 615-327-3234
Reported: June 25, 2014 Initiated: May 12, 2014 #D-1406-2014
Product Description
Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 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
- 100 mL
- Distribution
- Nationwide
- Location
- Nashville, TN
Frequently Asked Questions
What product was recalled? ▼
Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 Avenue N, Nashville, TN 37203, 615-327-3234. Recalled by John W Hollis Inc. Units affected: 100 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-1406-2014.
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