The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1811-2019·Announced 2019-08-21

Infusion Options Recalls RomiPLOStim Syringes Due to Sterility Concerns

Infusion Options, Inc. is recalling RomiPLOStim 700 MCG/1.4 ML SQ syringes in New York due to a lack of assurance of sterility.

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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in a medical injection product.

Plain-English summary

Infusion Options, Inc. is recalling RomiPLOStim 700 MCG/1.4 ML SQ syringes. The recall was initiated because of a lack of assurance of sterility for the product. The affected product is a prescription-only subcutaneous syringe manufactured by Infusion Options, Inc., located in Brooklyn, New York.

The recall is limited to New York. The source text does not specify particular lot numbers, stating only that all lots within expiry are affected. No specific dates or quantities are provided in the notice.

Consumers and healthcare providers in New York who have this product should contact Infusion Options, Inc. at 718-283-7233 for further instructions on how to handle the recalled syringes.

The recalled product

Product
RomiPLOStim 700 MCG/ 1.4 ML SQ SYR, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — Injectable
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 →

Related recalls

Same manufacturer · Infusion Options, Inc.

See all →

Same hazard · sterility

See all →

Similar recalls