The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1098-2019·Announced 2019-04-17

FDA Recalls PGE1-Lidocaine Injectable Due to Insanitary Compounding Conditions

Professional Compounding Pharmacy is recalling PGE1-Lidocaine injectable products because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.

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 source text explicitly states that no illnesses or injuries have been reported, which aligns with the rubric for a High severity score (risk-of-harm products where injury has not yet been reported).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE products manufactured by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy. The recall involves 25 prescriptions of 10 ml and 9 ml injectable vials. These products were dispensed in Oregon between September 1, 2018, and February 20, 2019.

The recall was initiated due to a lack of processing controls. Specifically, FDA inspectors observed insanitary conditions during the compounding of sterile drugs during a recent inspection. This classification indicates that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Patients who have received these specific prescriptions should contact their healthcare provider or the pharmacy for further instructions. The FDA has not reported any illnesses or injuries associated with this recall.

The recalled product

Product
PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Manufacturer
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
Category
Drug — Compounded Sterile Injectable
Hazard

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 (14)

  • Lot:(a) 26092018@22
  • 26092018@22
  • 09102018@47
  • 15102018@33
  • 29112018@4
  • 10122018@14
  • 19122018@20
  • 21122018@29
  • 27122018@20
  • (b) 16012019@59
  • 18012019@17
  • 21012019@49
  • 22012019@24
  • distributed between 09-01-2018 to 02-20-2019.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 25 recalled by Health Solutions Pharmacy Center Inc dba Professional 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 25 products in this recall →

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