The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0405-2017·Announced 2017-01-11

Wells Pharmacy Recalls Titan Up Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 433 vials of Titan Up Injectable because the product may lack 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. According to the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as lack of sterility in injectables) are categorized as Severe.

Plain-English summary

Wells Pharmacy Network LLC is recalling 433 vials of Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable. The product is a 25 mg/25 mg/1.5 mg/25 mg/0.025 mg/10 mg/mL, 30 mL vial compounded by Wells Pharmacy in Ocala, FL. The recall is due to a lack of assurance of sterility.

The recall covers all lot codes of the product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot codes include 03252016@4, 04012016@9, 04042016@9, 04132016@14, 05062016@3, 06022016@7, 06152016@22, 06292016@25, and 07282016@12. The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable 25 mg/25 mg/1.5 mg/25 mg/0.025 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer
Wells Pharmacy Network LLC
Category
Drug — Compounded Injectable
Hazard
Affected units
433

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 (10)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • within expiry. Known lot code: 03252016@4
  • 04012016@9
  • 04042016@9
  • 04132016@14
  • 05062016@3
  • 06022016@7
  • 06152016@22
  • 06292016@25
  • 07282016@12.

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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