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Recall Observatory FDA recall evidence

Drug product

Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10

D-1527-2016

September 15, 2016

Class III

Product summary

Firm
Mckesson Packaging Services
Event
Event 75215
Status
Terminated
Classification
Class III
Quantity
3,492 unit cartons of 10 x 10 blister cards
Official record key
drug-enforcement:D-1527-2016

Official wording

Reason: Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).

Code information: Lot #: 0111512; Exp. 08/17

Distribution pattern: CO, IL, LA, OH

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Missing

Field note

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