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Class III: unlikely to cause harmTerminated

Mckesson Packaging Services Xanax Recall

Xanax (Alprazolam) USP, CIV, 0

Mckesson Packaging Services · Concord, NC

Risk level
Class III
Reported by FDA
Oct 5, 2016
Recall ID
D-1527-2016
Check your lot numberHow we source this data

Summary

Mckesson Packaging Services recalled Xanax starting Sep 15, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1527-2016 on Oct 5, 2016. 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). Status: Terminated.

Why it was recalled

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).

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: 0111512; Exp. 08/17

Where it was sold

CO, IL, LA, OH

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1527-2016
Classification
Class III
Status
Terminated
Recall initiated
Sep 15, 2016
FDA report date
Oct 5, 2016
Quantity
3,492 unit cartons of 10 x 10 blister cards
Recall type
Voluntary: Firm initiated
Recalling firm
Mckesson Packaging Services

Original FDA data

Every field from FDA enforcement report D-1527-2016, exactly as published.

Show all FDA fields
City
Concord
State
NC
Status
Terminated
Country
United States
Event ID
75215
Address
7101 Weddington Rd NW
Code information
Lot #: 0111512; Exp. 08/17
Postal code
28027-3412
Report date
Oct 5, 2016
Product type
Drugs
Recall number
D-1527-2016
Classification
Class III
Recalling firm
Mckesson Packaging Services
Product quantity
3,492 unit cartons of 10 x 10 blister cards
Termination date
May 3, 2017
Reason for recall
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).
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
CO, IL, LA, OH
Recall initiation date
Sep 15, 2016
Initial firm notification
Letter
Center classification date
Sep 27, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1527-2016, published Oct 5, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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