The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1395-2014·Announced 2014-06-25

John W Hollis Recalls Levocarnitine Injection Due to Sterility Concerns

John W Hollis Inc. is recalling Levocarnitine Solution for injection because the company cannot ensure the product is sterile. The recall covers specific lots distributed nationwide.

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 involves a lack of sterility assurance in an injectable product, which poses a significant risk of serious health consequences such as infection or sepsis, meeting the criteria for a Severe rating.

Plain-English summary

John W Hollis Inc. is recalling Levocarnitine Solution for injection, 50 mL vials, due to a lack of assurance of sterility. The product is a compounded aseptically filled injectable solution containing l-Carnitine 50 mg, Sterile Water for Injection, and Benzyl Alcohol. The recall is classified as FDA Class II.

The affected product includes Lot 1731 with a use-by date of 7/01/14 and Lot 2190 with a use-by date of 8/24/14. The total quantity involved is 1,750 mL. The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected product and contact John W Hollis Inc. at 615-327-3234 for further instructions. The recall is being conducted to address the potential risk associated with the lack of sterility assurance in the compounded injectable products.

The recalled product

Product
Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Manufacturer
John W Hollis Inc
Category
Drug — Injectable Solution
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 (4)

  • Lot: 1731
  • Use by 7/01/14
  • Lot: 2190
  • Use by 8/24/14

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by John W Hollis Inc 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 19 products in this recall →

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