The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1130-2017·Announced 2017-09-13

ImprimisRx Recalls Curcumin Emulsion Injection Due to Undeclared Excipient

ImprimisRx is recalling Curcumin Emulsion 10mg/ml Injection vials because non-pharmaceutical grade PEG 40 Castor Oil was used due to supplier mislabeling.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the use of non-pharmaceutical grade excipients in an injectable medication presents a significant risk of adverse health consequences, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

ImprimisRx CA, Inc., dba ImprimisRx, is recalling 2,608 vials of Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration. The product was compounded for licensed professional or patient use and distributed nationwide.

The recall was initiated because non-pharmaceutical grade PEG 40 Castor Oil was used in the product due to a mislabeling error by the supplier. This resulted in an incorrect or undeclared excipient in the final compounded medication.

Patients and healthcare providers who have received or administered these specific vials should stop using them and contact ImprimisRx for further instructions. The affected lots are identified by specific lot codes and expiration dates ranging from June 19, 2017, to July 23, 2017.

The recalled product

Product
Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA
Manufacturer
ImprimisRx CA, Inc., dba ImprimisRx
Category
Drug — Compounded Injectable
Hazard
Affected units
2,608

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)

  • 03212017@21B Exp:6/19/2017
  • 03232017@19B Exp:6/21/2017
  • 03292017@27B Exp:6/27/2017
  • 03292017@9B Exp:6/27/2017
  • 04042017@21B Exp:7/3/2017
  • 04122017@22B Exp:7/11/2017
  • 04132017@14B Exp:7/12/2017
  • 04192017@37B Exp:7/18/2017
  • 04192017@17B Exp:7/18/2017
  • 04242017@18B Exp:7/23/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by ImprimisRx CA, Inc., dba ImprimisRx 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 4 products in this recall →

Related recalls

Same manufacturer · ImprimisRx CA, Inc., dba ImprimisRx

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Same hazard · undeclared excipient

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