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Recall Observatory FDA recall evidence

Drug product

Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

D-1397-2014

May 12, 2014

Class II

Product summary

Firm
John W Hollis Inc
Event
Event 68557
Status
Terminated
Classification
Class II
Quantity
365 mL
Official record key
drug-enforcement:D-1397-2014

Official wording

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

Code information: a) 5 mL: Lot: 2319, best used by 6/04/14; Lot: 2510, best used by 6/22/14; Lot: 2576, best used by 6/25/14; Lot: 2624, best by 6/30/14; Lot: 2744, best used by 7/08/14; Lot: 3048, best used by 7/30/14; Lot: 3062, best used by 7/31/14; Lot: 3106, best used by 8/6/14; b) 10 mL: Lot 2084, best used by 5/19/14; Lot 2318, best used by 6/04/14; Lot: 2369, best used by 6/10/04; Lot: 2396, best used by 6/11/14; Lot: 2576, best used by 6/25/14; Lot: 2744, best used by 7/08/14; Lot: 3062, best used by 7/31/14; Lot: 3106, best used by 8/6/14; Lot: 3123, best used by 8/10/14

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility