The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0637-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls CoEnzymeQ10 Vials Due to Sterility Concerns

Partell Specialty Pharmacy is recalling CoEnzymeQ10 25mg/mL vials because they were sterilized using a non-approved method.

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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Partell Specialty Pharmacy is recalling CoEnzymeQ10 25mg/mL, 5mL amber vials due to a lack of assurance of sterility. The recall is being conducted because the firm used a non-approved method of sterilization for these drug products.

The affected products are prescription-only and were distributed only in Nevada. The recall includes three vials with specific lot numbers and expiration dates: Lot 20171227@14 (BUD 03/27/2018), Lot 20180205@37 (BUD 05/06/2018), and Lot 20180214@30 (BUD 05/15/2018).

Consumers who have these specific vials should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Manufacturer
Partell Specialty Pharmacy
Category
Drug — Pharmacy Compounded
Hazard
Affected units
3

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#: 20171227@14
  • BUD 03/27/2018
  • 20180205@37
  • BUD 05/06/2018
  • 20180214@30
  • BUD 05/15/2018.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 49 recalled by Partell Specialty 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 49 products in this recall →

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