The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1004-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls Phenylephrine Vials Due to Sterility Concerns

Well Care Compounding Pharmacy is recalling Phenylephrine 0.5% vials because FDA inspections found violations that may affect 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a theoretical risk to sterility without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Well Care Compounding Pharmacy is recalling Phenylephrine 0.5% packaged in 5mL vials. The product is prescription-only and was distributed in Nevada. The recall involves a total of 869 units across five specific lots with expiration dates ranging from April 2016 to June 2016.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The agency classifies this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product
PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer
Well Care Compounding Pharmacy
Category
Drug — Compounded Sterile Preparation
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 (10)

  • Lot #: 01282016:60@3
  • Exp.04/28/2016
  • Lot #: 02242016: 90@20
  • Exp.05/24/2016
  • Lot #: 02222016:06@67
  • Exp. 05/24/2016
  • Lot #: 03082016:81@21
  • Exp.06/06/2016
  • Lot #: 03162016: 62@1
  • Exp. 06/14/2016.

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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