The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1276-2016·Announced 2016-07-20

Pharmakon Recalls Promethazine Compounded Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 485 units of compounded Promethazine 25 mg in 0.9% Sodium Chloride bags 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 and involves a lack of assurance of sterility in a compounded drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 485 units of Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and carries the NDC 45183-0187-41. The recall is being conducted because of a lack of assurance of sterility.

The affected products were distributed nationwide, including to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates.

Healthcare providers and patients should stop using the affected product and contact Pharmakon Pharmaceuticals for further instructions or a replacement. This recall is classified as Class II by the FDA.

The recalled product

Product
Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0187-41
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Compounded Sterile Product
Hazard
Affected units
485

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 (1)

  • All Sterile Compounded Products within Expiry

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 88 recalled by Pharmakon Pharmaceuticals, 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 88 products in this recall →

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