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Recall Observatory FDA recall evidence

Drug product

Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.

D-1061-2013

August 30, 2013

Class III

Product summary

Firm
Watson Laboratories Inc
Event
Event 66169
Status
Terminated
Classification
Class III
Quantity
875 bottles
Official record key
drug-enforcement:D-1061-2013

Official wording

Reason: Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.

Code information: Lot 706224A and 706225A, Exp. 04/15.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.

Field note

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