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Recall Observatory FDA recall evidence

Drug product

ALPROSTADIL/PROCAINE, Injectable Solution, 20 MCG/0.1%/ML, 10 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0056-2016

July 24, 2015

Class II

Product summary

Firm
JD & SN Inc., dba Moses Lake Professional Pharmacy
Event
Event 71806
Status
Terminated
Classification
Class II
Quantity
150 vials
Official record key
drug-enforcement:D-0056-2016

Official wording

Reason: Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Code information: 01122015@4, 02022015@2, 02102015@29, 02202015@14, 03302015@9, 04132015@7, 04222015@4, 05062015@6, 05132015@2, 05272015@11, 06032015@1, 06102015@6, 06222015@9, 06232014@2, 07082015@4, 07112014@22, 07292014@33, 08182014@8, 09022014@5, 09092014@27, 09172014@3, 10082014@3, 10272014@2, 11052014@2, 11262014@4, t03062015@44, t03242015@26, t06242015@8, t07182014@23, t11102014@21, and t12292014@19.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility