The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1676-2019·Announced 2019-08-14

RXQ Compounding Recalls Manganese Sulfate Injection Due to Sterility Concerns

RXQ Compounding LLC is recalling Manganese Sulfate Monohydrate Injection because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

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, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable products) are categorized as Severe (Score 4), particularly when structural or significant safety defects are involved, even if specific hospitalization reports are not detailed in the brief source text provided.

Plain-English summary

RXQ Compounding LLC is recalling Manganese Sulfate Monohydrate (PFV) 0.1mg/mL Injection, 10 mL per syringe, under NDC 70731-0952-10. The recall is being conducted because the product lacks assurance of sterility. The affected product is distributed nationwide in the United States.

The recall includes all lots of the product that are within their expiration dates. 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.

Healthcare providers and patients should stop using the recalled product and contact their healthcare provider for further instructions. Consumers should not use the product and should return it to the pharmacy or point of purchase if directed by their healthcare provider.

The recalled product

Product
MANGANESE SULFATE MONOHYDRATE (PFV) 0.1MG/ML INJ, 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0952-10
Manufacturer
RXQ Compounding LLC
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 nationwide across the United States.

Part of a larger recall action

This product is one of 86 recalled by RXQ Compounding LLC 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 86 products in this recall →

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