Agency classClass IIOur severity:High FDA (Drugs)·D-0186-2023·Announced 2023-02-01

Injectable chlorpheniramine/hyoscyamine recalled for sterility assurance failure

Pharmacy Innovations has recalled Chlorpheniramine/Hyoscyamine injectable medication nationwide due to insanitary facility conditions identified during FDA inspection that compromise product 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 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: This FDA Class II recall involves a high-risk product category (sterile injectables) with documented sterility assurance failure from facility conditions. No reported illnesses or injuries appear in the source material, placing this at Score 3 (High) per the rubric criterion for risk-of-harm products without documented injury.

Plain-English summary

Pharmacy Innovations, located at 2936 W 17th St., Erie, Pennsylvania, has recalled Chlorpheniramine/Hyoscyamine 10 mg/0.25 mg per 1 mL injectable medication nationwide. An FDA inspection revealed insanitary conditions at the manufacturing facility that compromise the sterility assurance for this injectable product.

Chloropheniramine/Hyoscyamine is an Rx-only antihistamine and anticholinergic medication administered by injection. The recalled product code is t20221026@41 and was distributed nationwide. Injectable medications require strict sterility to ensure safety.

Healthcare providers who have this product should verify their inventory and quarantine any affected units. Patients who have received this medication should contact their healthcare provider regarding potential exposure from this recall.

The recalled product

Product: Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable / Antihistamine
Hazard: lack-of-sterility
contamination-risk

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)

t20221026@41

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 59 recalled by Pharmacy Innovations 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 59 products in this recall →

Same manufacturer · Pharmacy Innovations

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Same hazard · lack of sterility