The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0421-2017·Announced 2017-01-11

Wells Pharmacy Recalls Vitamin D3 Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 335 vials of Vitamin D3 in Sesame Oil Injectable due to 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, and the rubric specifies that FDA Class II recalls with potential for serious injury (implied by sterility failure in an injectable) fall under the Severe category.

Plain-English summary

Wells Pharmacy Network LLC is recalling 335 vials of Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product was compounded by Wells Pharmacy in Ocala, FL, and distributed nationwide. The recall covers all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. Known lot codes include 04202016@1, 05052016@6, 06062016@1, and 08012016@34.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer
Wells Pharmacy Network LLC
Category
Drug — Compounded Injectable
Hazard
Affected units
335

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 (5)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • within expiry. Known lot code: 04202016@1
  • 05052016@6
  • 06062016@1
  • 08012016@34.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 97 recalled by Wells Pharmacy Network LLC 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 97 products in this recall →

Related recalls

Same manufacturer · Wells Pharmacy Network LLC

See all →

Same hazard · sterility failure

See all →

Similar recalls