The Recall Desk
SevereFDA (Drugs)·D-1397-2014·Announced 2014-06-25

John W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns

John W Hollis Inc is recalling specific lots of compounded injectable products containing papaverine, phentolamine, and alprostadil due to a lack of sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or infection.

Plain-English summary

John W Hollis Inc is recalling specific lots of compounded injectable products containing papaverine HCl, phentolamine mesylate, and alprostadil. The recall is being conducted because of a lack of assurance of sterility in these aseptically filled products.

The affected products are available in 5 mL and 10 mL volumes. Specific lot numbers and expiration dates are listed in the structured product information. The recall covers a nationwide distribution pattern.

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

The recalled product

Product
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Manufacturer
John W Hollis Inc
Category
Drug — Compounded Injectable
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 (20)

  • a) 5 mL: Lot: 2319
  • best used by 6/04/14
  • Lot: 2510
  • best used by 6/22/14
  • Lot: 2576
  • best used by 6/25/14
  • Lot: 2624
  • best by 6/30/14
  • Lot: 2744
  • best used by 7/08/14
  • Lot: 3048
  • best used by 7/30/14
  • Lot: 3062
  • best used by 7/31/14
  • Lot: 3106
  • best used by 8/6/14
  • b) 10 mL: Lot 2084
  • best used by 5/19/14
  • Lot 2318
  • Lot: 2369

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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Same hazard · sterility

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