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LUPIN -Product Recall Notification - Zolpidem Tartrate Sublingual Tablets 1.75mg & 3.5mg - 5-10-16


URGENT!!!            DRUG RECALL!!!             URGENT!!!

NDC                       LABEL NAME                                                                          LOTS           EXPIRATION
433860796230    ZOLPIDEM TARTRATE SUBLINGUAL TABLETS 1.75 mg    M16140A         02/2018
433860796130    ZOLPIDEM TARTRATE SUBLINGUAL TABLETS 3.5 mg      M16140A         02/2018


Gavis Pharmaceuticals LLC is voluntarily recalling two (2) lots of ZOLPIDEM TARTRATE SUBLINGUAL TABLETS 1.75 mg & 3.5mg (30 count cartons). These lots are being recalled as the current packaging for this product may not meet the child-resistance standards as required by the Poison Prevention Packaging Act (PPPA).

There is no risk to the consumer to use the drug as directed since the product continues to meet all quality requirements specified by the FDA. However, the child-resistance of the packaging may not meet PPPA standards, increasing the chance that young children could gain unintended access to the tablets, posing a risk of overdose.

This recall is being made with the knowledge of the Consumer Product Safety Commission.

The recalled lots were distributed between March 21, 2016 to May 6, 2016 to wholesalers and distributors nationwide.

Contact:

GAVIS: GAVIS CUSTOMER SERVICE 908-603-6080