The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0326-2015·Announced 2014-12-31

Neolpharma Recalls Subpotent Alprazolam Tablets Nationwide

Neolpharma, Inc. is voluntarily recalling 12,310 bottles of 0.25 mg alprazolam tablets nationwide because the medication was found to be subpotent.

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 for a subpotent drug. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).

Plain-English summary

Neolpharma, Inc. is voluntarily recalling 12,310 bottles of Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only. The affected products are distributed by Greenstone LLC and are available in 500-count and 1,000-count bottles. The recall covers two specific lots: Lot C100429 (Expiration 03/15) and Lot C120293 (Expiration 01/17).

The recall was initiated because the medication was identified as subpotent, meaning it did not contain the full amount of the active ingredient required by the United States Pharmacopeia (USP). The FDA classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed in the recall notice. Those who have purchased or received these specific bottles should contact their pharmacist or the recalling firm for instructions on how to return the product or obtain a replacement.

The recalled product

Product
ALPRAZOLAM (ALPRAZOLAM)
Brand
ALPRAZOLAM
Manufacturer
Neolpharma, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
12,310

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 (4)

  • Lot #: a) C100429
  • Exp 03/15
  • b) C120293
  • Exp 01/17

Distribution

Distributed nationwide across the United States.

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