The Recall Desk
HighFDA (Drugs)·D-0227-2023·Announced 2023-02-01

Injectable drug products recalled due to unsanitary manufacturing conditions

Pharmacy Innovations is recalling injectable PE1/PAPAV/ATROP/CHLORPROM drugs due to insanitary facility conditions that compromise product sterility. FDA inspection found conditions that do not ensure the safety of these injectable medications.

What this means for you

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: This is an FDA Class II recall of injectable drugs where sterility assurance is compromised due to documented insanitary conditions at the manufacturing facility. While the hazard is significant, no injuries or illnesses have been reported, making this a risk-of-harm scenario without reported harm—scored at most 3 per the rubric.

Plain-English summary

Pharmacy Innovations is recalling injectable formulations of PE1/PAPAV/ATROP/CHLORPROM at various concentrations (7 mcg, 100 mcg, 15 mcg, and 30 mcg per mL in 1 mL vials). These products are manufactured at the company's facility located in Erie, Pennsylvania and were distributed nationwide in the United States.

The FDA inspected the manufacturing facility and identified insanitary conditions. Injectable medications must maintain sterility to ensure safety and efficacy. The insanitary conditions found at the facility mean that the affected products cannot provide assurance of sterility. This recall was classified by the FDA as a Class II recall.

Affected batch codes include t20221025@7, t20221116@36, 20221114@41, and t20221117@5.

The recalled product

Product
PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 15MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 30MCG/8.7MG/0.1MG/1.8MG/ML (
Manufacturer
Pharmacy Innovations
Category
Drug — Injectable Drugs
Hazard
  • lack-of-sterility
  • contamination-risk

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 (1)

  • t20221025@7 t20221116@36 20221114@41 t20221117@5 t20221116@36

Distribution

Distributed nationwide across the United States.

Related recalls

Same category