Hartley Medical Center Pharmacy Recalls Sufentanil Citrate Syringes Due to Sterility Concerns
Hartley Medical Center Pharmacy is recalling Sufentanil Citrate/Clonidine/Bupivacaine syringes because the agency could not ensure the product was sterile.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a Severe rating under the rubric for drug recalls involving potential serious health consequences.
Plain-English summary
Hartley Medical Center Pharmacy, Incorporated is recalling Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, 20 ml syringes. The recall was initiated due to a lack of assurance of sterility for the product.
The affected product is a prescription-only medication distributed nationwide. The specific lot identified in the recall has a beyond-use date of May 3, 2016. No foreign distribution is reported.
Consumers and healthcare providers should stop using the recalled syringes and contact their pharmacist or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
- Manufacturer
- Hartley Medical Center Pharmacy, Incorporated
- Category
- Drug — Injectable Medication
- 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.
See all 30 products in this recall →Related recalls
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