Sandoz Alprazolam Tablets Recalled for Stainless Steel Metal Particulates
Mckesson Packaging Services is recalling Sandoz Alprazolam Tablets 0.25 mg due to the presence of stainless steel metal particulates.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a foreign substance (metal particulates) in a medication, which poses a risk of harm even without reported injuries.
Plain-English summary
Mckesson Packaging Services is recalling 1,240 boxes (124,000 tablets) of Alprazolam Tablets, USP 0.25 mg, manufactured by Sandoz, Inc. The recall is due to the presence of a foreign substance, specifically stainless steel metal particulates, within the tablets.
The affected product is identified by NDC 63739-644-10, Lot 102492, and an expiration date of 01/2016. The distribution pattern indicates the product was shipped to Colorado and Ohio.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10
- Manufacturer
- Mckesson Packaging Services
- Category
- Drug — Tablets
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 102492
- exp 01/2016
Distribution
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