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Recall Observatory FDA recall evidence

Drug product

Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

D-1402-2014

May 12, 2014

Class II

Product summary

Firm
John W Hollis Inc
Event
Event 68557
Status
Terminated
Classification
Class II
Quantity
25 mL
Official record key
drug-enforcement:D-1402-2014

Official wording

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

Code information: a) 5 mL: Lot: 2488, best used by 6/19/14; b) 10 mL: Lot: 2264, best used by 06/03/14; Lot: 2295, best used by 06/04/14

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility