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Recall Observatory FDA recall evidence

Drug product

Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09

D-0793-2016

February 12, 2016

Class II

Product summary

Firm
Walter's Pharmacy
Event
Event 73336
Status
Terminated
Classification
Class II
Quantity
22 bottles
Official record key
drug-enforcement:D-0793-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 112015, 112715, 113015,120515, 120715, 121215, 121515, 122115, 010516, 010716, 010816, 011116, 012016, 012816, 012916, 020316, 020416, 020516.

Distribution pattern: PA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility