The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0730-2017·Announced 2017-05-24

Key Pharmacy Recalls Papaverine/Phentolamine Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine injection because the firm cannot assure the sterility of the product.

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 source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterile compounded drugs where sterility assurance is compromised.

Plain-English summary

Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine 5mL Multiple Dose Vials. The recall is being conducted because the firm lacks assurance of the sterility of these compounded sterile drugs.

The affected product is a prescription-only injection containing 30mg/1mg/mL of Papaverine and Phentolamine. The recall covers four vials from three specific lots: t12-21-2016@110 (expiring 6/20/2017), t12-27-2016@84 (expiring 6/26/2017), and t12-30-2016@74 (expiring 7/2/2017). These products were distributed nationwide in the U.S.A., as well as in Australia and Canada.

Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the product. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
4

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 (6)

  • Lot # t12-21-2016@110
  • Exp 6/20/2017
  • t12-27-2016@84
  • Exp 6/26/2017
  • t12-30-2016@74
  • Exp 7/2/2017.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Key Pharmacy and Compounding Center 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 79 products in this recall →

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