Hartley Medical Center Pharmacy Recalls Sufentanil and Baclofen Syringes
Hartley Medical Center Pharmacy is recalling Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml syringes due to a lack of assurance of sterility.
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 and involves a lack of assurance of sterility in a drug product, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Hartley Medical Center Pharmacy, Incorporated is recalling Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, 20 ml syringes. The recall is being conducted because of a lack of assurance of sterility. The affected product is prescription-only and was distributed nationwide, with no foreign distribution.
The specific product code is identified by a Beyond Use Date (BUD) of 5/3/2016. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific number of affected units is stated in the source text.
Consumers and healthcare providers should stop using the affected syringes and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
- Manufacturer
- Hartley Medical Center Pharmacy, Incorporated
- Category
- Drug — Pharmacy Compounded
- Hazard
- Affected units
- 1
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)
- BUD: 5/3/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Hartley Medical Center Pharmacy, Incorporated 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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