The Recall Desk
LowFDA (Drugs)·D-1527-2016·Announced 2016-10-05

Mckesson Recalls Xanax Tablets Due to Missing Primary Packaging Labels

Mckesson Packaging Services is recalling 3,492 cartons of Xanax (Alprazolam) 0.5 mg tablets because the primary blister card labels are blank and lack product information.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a packaging and labeling defect (missing primary label) rather than a contamination or structural defect.

Plain-English summary

Mckesson Packaging Services is recalling 3,492 unit cartons of Xanax (Alprazolam) USP, CIV, 0.5 mg tablets. The product is identified by NDC 63739-669-10, Lot # 0111512, and an expiration date of 08/17. The recall was initiated because the primary packaging labels, specifically the blister cards, are blank and do not contain required product information such as the product name, strength, lot number, or expiry date.

The affected units were distributed to Colorado, Illinois, Louisiana, and Ohio. The tablets were manufactured by Sandoz Inc. in Princeton, NJ, and packaged by Mckesson Packaging Services.

Consumers who possess this specific lot of Xanax should stop using the product and contact their healthcare provider or pharmacist for guidance. Because the primary labels are missing, patients may be unable to verify the identity or strength of the medication, which poses a risk of medication errors.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 0111512
  • Exp. 08/17

Distribution

Distributed in 4 states: