The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1290-2016·Announced 2016-07-20

Pharmakon Recalls Provocholine Syringes Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 142 units of Provocholine pre-diluted syringes nationwide 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 drug product, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 142 units of Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes. The affected products are prescription-only (Rx Only) and come in various concentrations, including 0.0625mg/mL, 0.25 mg/mL, 1 mg/mL, 4 mg/mL, and 16 mg/ml, each in 3 mL syringes. The products were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana.

The recall was initiated due to a lack of assurance of sterility. The source text does not specify a particular pathogen or contamination event, but indicates that the sterility of the compounded products could not be guaranteed. The recall covers all sterile compounded products within their expiry dates.

The products were distributed nationwide, with specific distribution to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. Consumers and healthcare providers should stop using the affected syringes and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions.

The recalled product

Product
Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Sterile Compounded Drug
Hazard
Affected units
142

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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