Beacon Hill Medical Pharmacy Recalls Oxytocin Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Oxytocin 10 Units/mL because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
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. According to the rubric, an FDA Class II recall involving a sterile injectable product where sterility assurance is compromised is categorized as Severe (Score 4), as it poses a significant risk of infection or injury.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling Oxytocin 10 Units/mL, all presentations, for intravenous and subcutaneous use only. The product was compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, MI, and distributed nationwide in the USA.
The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.
Affected lots include those with codes 03212013@12, 01112013@20, 03072013@19, and 05082013@27. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
- Category
- Drug — Injectable
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 (4)
- 03212013@12
- 01112013@20
- 03072013@19
- and 05082013@27
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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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