Hospira Recalls Labetalol Hydrochloride Injection Due to Cracked Glass Vials
Hospira Inc. is recalling Labetalol Hydrochloride Injection vials because of cracked glass at the rim, which is covered by the stopper and crimp seal.
What this means for you
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. The defect involves cracked glass covered by the stopper and crimp seal, which poses a potential risk of glass particulate contamination but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
Hospira Inc. A Pfizer Company is recalling Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vials. The recall is due to a defect in the glass vials, specifically cracked glass at the rim surface that is covered by the stopper and crimp seal.
The affected products are labeled as Hospira, Inc. (NDC 0409-2267-20) and NOVAPLUS, Manufactured by Hospira, Inc. (NDC 0409-2267-25). The recall includes 137,975 vials of the Hospira-labeled product and 40,143 vials of the NOVAPLUS-labeled product. Specific lots affected are 74370DD (Exp 1FEB2019), 75035DD and 75115DD (Exp 1MAR2019) for the Hospira label, and 74230DD (Exp 1FEB2019) for the NOVAPLUS label.
These products were distributed nationwide in the USA and Puerto Rico. Healthcare providers and patients should check their inventory for these specific NDCs and lot numbers. If found, the vials should be quarantined and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
- Brand
- LABETALOL HYDROCHLORIDE
- Manufacturer
- Hospira Inc. A Pfizer Company
- Category
- Drug — Injection
- 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 (6)
- Lots: a) 74370DD
- Exp 1FEB2019
- 75035DD
- 75115DD
- Exp 1MAR2019
- b) 74230DD
Distribution
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