Health Innovations Pharmacy Recalls Glycopyrrolate Suspension Due to Sterility Concerns
Health Innovations Pharmacy is recalling Glycopyrrolate 0.2 mg/1 mL Suspension (Robinul) because inspection findings indicate a lack of assurance regarding sterility and stability data.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant quality assurance risks like sterility failures in injectable medications.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling all lots of Glycopyrrolate 0.2 mg/1 mL Suspension (Robinul). The product was distributed in North Carolina.
The recall was initiated due to recent inspection observations associated with certain quality control procedures. These observations present a risk to sterility and quality assurance, specifically regarding the lack of assurance of sterility and stability data supporting the product's expiry.
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
- Glycopyrrolate 0.2 mg/1 mL Susp (Robinul), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Injectable
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
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 65 recalled by Health Innovations Pharmacy, 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.
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