The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0648-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Naltrexone Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Naltrexone 200 mg pellets because a non-approved sterilization method was used, creating a lack of assurance of sterility.

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 severity score under the rubric, particularly given the risk of infection associated with non-sterile injectable medications.

Plain-English summary

Partell Specialty Pharmacy is recalling Naltrexone 200 mg pellets, packaged in amber vials and marked for prescription use only. 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 identified by Lot Number 20180219@90 and has a beyond-use date of August 18, 2018. Distribution was limited to the state of Nevada.

Consumers who have this specific lot of Naltrexone pellets should stop using the product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Naltrexone 200 mg pellet, 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 — 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 (2)

  • Lot#: 20180219@90
  • BUD 08/18/2018

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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