The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0050-2016·Announced 2015-10-21

Bedford Pharmacy Recalls P-P-P Injection Due to Sterility Concerns

Bedford Pharmacy is recalling P-P-P (COBAL) 30-2-30/mL injections because of a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Bedford Pharmacy is voluntarily recalling P-P-P (COBAL) 30-2-30/mL injections. The recall was initiated due to a lack of assurance of sterility for the product. The specific lot number is 07112015@5, with an expiration date of 09/29/2015.

The affected product was distributed in New Hampshire and Massachusetts. Each unit consists of 1 vial. The recall is classified as Class II by the U.S. Food and Drug Administration.

Consumers and healthcare providers who have this specific lot of P-P-P (COBAL) 30-2-30/mL injection should stop using it and contact Bedford Pharmacy at (603) 472-3919 for further instructions or a refund.

The recalled product

Product
P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Manufacturer
Bedford Pharmacy
Category
Drug — Injection
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 #: 07112015@5
  • Exp 09/29/2015

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 13 recalled by Bedford 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 13 products in this recall →

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