PharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
PharMEDium Services is recalling 46 lots of rocuronium bromide syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.
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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or property damage (implied by lack of sterility assurance in IV products) are classified as Severe (Score 4).
Plain-English summary
PharMEDium Services, LLC is recalling 46 lots of rocuronium bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use. The recall is being conducted because of a lack of sterility assurance. The affected products are preservative-free and carry the NDC 71019-321-10.
The recall covers 4,625 units of the product. The specific lot codes involved are 193510017D (expiration 3/17/2020), 193530001D (expiration 3/19/2020), and 193540002D (expiration 3/22/2020). The products were distributed nationwide in the US.
The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with the recalled products.
The recalled product
- Product
- rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 4,625
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)
- 193510017D 3/17/2020 193530001D 3/19/2020 193540002D 3/22/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by PharMEDium Services, 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.
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