The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0016-2020·Announced 2019-10-09

Colonia Care Pharmacy Recalls C-MB12/HB12 Injection Due to Sterility Concerns

Colonia Care Pharmacy is recalling six syringes of C-MB12/HB12 5MG/5MG/ML Injection Solution because the product's sterility cannot be guaranteed. The affected lot was distributed via 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe) and cannot be scored lower, regardless of the specific hazard description.

Plain-English summary

Colonia Care Pharmacy is recalling six syringes of C-MB12/HB12 5MG/5MG/ML Injection Solution, 0.9 mL in a 3 mL syringe. The recall is being conducted because the product's sterility cannot be guaranteed, meaning there is a lack of assurance that the medication is free from microbial contamination.

The affected product is identified by Lot # 071819C with a Beyond Use Date (BUD) of 09/01/19. The recall number is D-0016-2020. The product was distributed through patient-specific prescriptions in New Jersey.

Patients who have received this specific medication should contact their healthcare provider or pharmacist for guidance on what to do next. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Manufacturer
Colonia Care Pharmacy
Category
Drug — Pharmacy Compounded
Hazard
Affected units
6

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 #: 071819C
  • BUD 09/01/19

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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