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Recall Observatory FDA recall evidence

Drug product

15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3.

D-1126-2019

March 12, 2019

Class II

Product summary

Firm
MSM Nutraceuticals, LLC
Event
Event 82421
Status
Terminated
Classification
Class II
Quantity
5000 30 ml bottles
Official record key
drug-enforcement:D-1126-2019

Official wording

Reason: Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Code information: Lot # 1808051, Exp. Date 01/01/22

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility