The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0034-2020·Announced 2019-10-09

Colonia Care Pharmacy Recalls Verapamil Injection Due to Sterility Concerns

Colonia Care Pharmacy is recalling Verapamil 2.5mg/mL injection vials because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

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. According to the rubric, FDA Class II recalls with potential for serious injury (such as sterility issues in injectable drugs) are classified as Severe.

Plain-English summary

Colonia Care Pharmacy is recalling C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vials, due to a lack of assurance of sterility. The specific reason for the recall is that the product's sterility cannot be guaranteed.

The affected product is identified by Lot # 072319A with a Beyond Use Date (BUD) of 09/06/19. The recall is limited to patient-specific prescriptions distributed in New Jersey.

Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on next steps. The recall is classified as Class II by the FDA.

The recalled product

Product
C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Manufacturer
Colonia Care Pharmacy
Category
Drug — Injectable
Hazard
Affected units
1

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 (2)

  • Lot #: 072319A
  • BUD 09/06/19

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 32 recalled by Colonia Care Pharmacy 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 32 products in this recall →

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