The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0420-2017·Announced 2017-01-11

Wells Pharmacy Recalls Vitamin D3 Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 237 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, which corresponds to a Severe severity score per the rubric, as it involves a potential health risk (lack of sterility) that could lead to serious temporary or medically reversible health consequences.

Plain-English summary

Wells Pharmacy Network LLC is recalling 237 vials of Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The affected product includes all lot codes prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. Known lot codes include 04112016@23, 05132016@3, 06062016@7, and 06272016@17.

Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the recalled description.

The recalled product

Product
Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer
Wells Pharmacy Network LLC
Category
Drug — Compounded Injectable
Hazard
Affected units
237

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: 04112016@23
  • 05132016@3
  • 06062016@7
  • 06272016@17.

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 →

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