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Recall Observatory FDA recall evidence

Drug product

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

D-1388-2014

May 12, 2014

Class II

Product summary

Firm
John W Hollis Inc
Event
Event 68557
Status
Terminated
Classification
Class II
Quantity
300 mL
Official record key
drug-enforcement:D-1388-2014

Official wording

Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Code information: Lot 563.61, use by 05/31/14; Lot 2616, Use by 3/31/15

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility

Field note

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