The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0634-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Ascorbic Acid Vials Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Ascorbic Acid (Tapioca) 500 mg/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 specific lots of Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vials. The recall is being conducted because the firm used a non-approved method of sterilization for these drug products, resulting in a lack of assurance of sterility.

The affected product is prescription-only and was distributed only in Nevada. The recall includes four vials from the following lots: 20180201@34 (expiration 04/02/2018), 20180202@56 (expiration 04/03/2018), 20180129@41 (expiration 3/30/2018), and 20180207@16 (expiration 04/08/2018).

Consumers and healthcare providers should stop using these products and contact Partell Specialty Pharmacy at (702) 791-3800 for further instructions.

The recalled product

Product
Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL 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 — Sterile Injectable
Hazard
Affected units
4

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 (8)

  • Lot#: 20180201@34
  • BUD 04/02/2018
  • 20180202@56
  • BUD 04/03/2018
  • 20180129@41
  • BUD 3/30/2018
  • 20180207@16
  • BUD 04/08/2018.

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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