The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0041-2016·Announced 2015-10-21

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

Bedford Pharmacy is recalling 4 vials of P-P-P (COBAL) 30-1-20/mL Injection due to 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 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, and the rubric specifies that FDA Class II recalls with potential for hospitalization or significant injury are rated as Severe (4).

Plain-English summary

Bedford Pharmacy is recalling 4 vials of P-P-P (COBAL) 30-1-20/mL Injection. The recall was initiated because of a lack of assurance of sterility for the product. The specific lot number is 08132015@9, with an expiration date of 09/27/2015.

The affected product was distributed in New Hampshire and Massachusetts. The recall is classified as FDA Class II by the U.S. Food and Drug Administration.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Manufacturer
Bedford Pharmacy
Category
Drug — Injection
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 (2)

  • Lot #: 08132015@9
  • Exp 09/27/2015

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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