Safecor Recalls Midazolam Syrup Cups Due to Cardboard Contaminant
Safecor Health is recalling specific lots of Midazolam HCl Syrup unit dose cups found to contain a small piece of cardboard.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a foreign substance (cardboard) with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Safecor Health, LLC is recalling specific lots of Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups. The recall was initiated after a customer complaint reported that one unit dose cup contained a small piece of cardboard contaminant.
The affected product is Cherry Brandy Flavor, prescription-only syrup manufactured by Roxane and packaged by Safecor Health in Woburn, MA. The specific lot number is 932333, with an expiration date of 08/04/16. The product was distributed in New York (NY).
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or Safecor Health for further instructions.
The recalled product
- Product
- Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.
- Manufacturer
- Safecor Health, LLC
- Category
- Drug — Liquid Oral
- Hazard
- Affected units
- 132
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 (2)
- Lot: 932333
- Exp 08/04/16
Distribution
Distributed in 1 state:
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