The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1389-2014·Announced 2014-06-25

John W Hollis Inc Recalls Liver Derivative Complex Injection for Sterility Concerns

John W Hollis Inc is recalling specific lots of Liver Derivative Complex for injection due to a lack of assurance of sterility in the compounded aseptically filled products.

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 injectable products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

John W Hollis Inc is recalling specific lots of Liver Derivative Complex for injection. The product is a compounded prescription medication containing Liver Derivative Complex, Water for Injection, Phenol, and pH adjusters. The recall involves 1,560 mL of the product distributed nationwide.

The recall was initiated due to a lack of assurance of sterility in the compounded aseptically filled injectable products. The affected lots include Lot #938 (Use by 08/17/14), Lot #1370 (Use by 11/08/14 or 1/30/15), and Lot #2664 (Use by 4/18/15).

Consumers and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found. The FDA has classified this as a Class II recall.

The recalled product

Product
Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5%, HCl or NaOH to adjust pH, 10 mL, Compounded by Prescription: JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203…
Manufacturer
John W Hollis Inc
Category
Drug — Injectable Compounded
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 (8)

  • Lot# 938
  • Use by 08/17/14
  • Lot #1370
  • Use by Lot# 1818
  • Use by 11/08/14
  • 1/30/15
  • Lot# 2664
  • Use by 4/18/15

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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