The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0979-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls Alpha Lipoic Acid Vials for Sterility Concerns

Well Care Compounding Pharmacy is recalling Alpha Lipoic Acid 25mg/mL vials due to FDA inspection findings of GMP violations that may impact sterility.

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 involves a risk-of-harm product (sterility issues) where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling Alpha Lipoic Acid 25mg/mL, packaged in 5mL vials, which is available by prescription only. The recall involves 869 units distributed in Nevada.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The specific lot numbers affected are 01252016:40@31 (Exp. 04/27/2016), 03072016:78@19 (Exp. 06/6/2016), and 02222016:71@35 (Exp. 05/27/2016).

Patients who have received this medication should contact their healthcare provider for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer
Well Care Compounding Pharmacy
Category
Drug — Compounded Medication
Hazard
Affected units
869

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 (6)

  • Lot #: 01252016:40@31
  • Exp. 04/27/2016
  • Lot #: 03072016:78@19
  • Exp. 06/6/2016
  • Lot #: 02222016:71@35
  • Exp. 05/27/2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Well Care Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 51 products in this recall →

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