The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1756-2019·Announced 2019-08-21

Infusion Options Recalls Carboplatin Infusions Due to Sterility Concerns

Infusion Options, Inc. is recalling various Carboplatin infusion bags because the company cannot guarantee the products are sterile.

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 identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a drug with a sterility defect (which implies a risk of serious infection) falls under the 'Severe' category, as it is not a Class I recall but involves a significant potential hazard.

Plain-English summary

Infusion Options, Inc. is recalling multiple lots of Carboplatin intravenous infusion bags (IVPB) in various concentrations and volumes. The recall is being conducted because the company lacks assurance of the sterility of these products. The affected products are prescription-only medications manufactured by Infusion Options, Inc. in Brooklyn, New York.

The recall covers a wide range of Carboplatin concentrations, including 174 mg, 240 mg, 750 mg, 895 mg, 235 mg, 716 mg, 400 mg, 500 mg, 575 mg, 307 mg, 766 mg, 684 mg, 260 mg, 360 mg, 274 mg, 780 mg, 140 mg, 408 mg, 847 mg, 560 mg, 180 mg, 200 mg, 238 mg, and 229.4 mg, mixed with Normal Saline (NS), Sodium Chloride (NaCl) 0.9%, or Dextrose 5% in Water (D5W). The distribution of these products was limited to New York. All lots within their expiration dates are affected.

Consumers and healthcare providers who have these products should stop using them and contact Infusion Options, Inc. at 718-283-7233 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, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARBOPLATIN 750 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 895 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 235 MG / 250ml NS IVPB CARBOPLATIN 716 MG / 250 ML D5W IVPB; CARBOPLATIN 400 MG / 500 ML NS IVPB…
Manufacturer
Infusion Options, Inc.
Category
Drug — Antineoplastic
Hazard

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 (1)

  • All lots within expiry

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 76 recalled by Infusion Options, Inc. 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 76 products in this recall →

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