The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0018-2020·Announced 2019-10-09

Colonia Care Pharmacy Recalls C-Methylcobalamin Injections Due to Sterility Concerns

Colonia Care Pharmacy is recalling 191 syringes of C-Methylcobalamin 25mg/mL injection because the product's sterility cannot be guaranteed.

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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a structural defect or significant risk (such as lack of sterility in an injectable drug) is categorized as Severe.

Plain-English summary

Colonia Care Pharmacy is recalling 191 syringes of C-Methylcobalamin 25mg/mL Injection PFS. The product is packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes and is available by prescription only. The recall was initiated because the sterility of the product cannot be guaranteed.

The affected lots are 020719A with a beyond-use date of 08/06/19, and 051619E with a beyond-use date of 11/12/19. These products were distributed via patient-specific prescriptions in New Jersey.

Patients who have received this medication should contact their healthcare provider for further instructions. 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-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Manufacturer
Colonia Care Pharmacy
Category
Drug — Injectable
Hazard
Affected units
191

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 (4)

  • Lot #: 020719A
  • BUD 08/06/19
  • 051619E
  • BUD 11/12/19

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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