The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0635-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls B-Complex Vials Due to Sterility Concerns

Partell Specialty Pharmacy is recalling specific lots of B-complex injectable vials because a non-approved sterilization method was used.

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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug is a significant hazard that aligns with the Severe classification for Class II recalls.

Plain-English summary

Partell Specialty Pharmacy is recalling 5 mL amber vials of B-complex (B1-200mg, B2-4mg, B3-200mg, B5-4mg, B6-4mg) /mL. The recall involves five specific lots with expiration dates ranging from March 27, 2018, to April 14, 2018. These prescription-only products were distributed only in Nevada.

The recall was initiated because the firm used a non-approved method of sterilization for these drug products. This lack of assurance regarding sterility poses a potential risk to patients.

Consumers and healthcare providers should stop using the affected vials and contact Partell Specialty Pharmacy at (702) 791-3800 for further instructions or to return the product.

The recalled product

Product
B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 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 — Injectable
Hazard
Affected units
5

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#: 20180205@18
  • BUD 04/06/2018
  • 20180126@28
  • BUD 03/27/2018
  • 20180126@22
  • 20180205@9
  • 20180214@17
  • BUD 04/14/2018.

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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