Beacon Hill Medical Pharmacy Recalls L-Tryptophan Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling L-Tryptophan 300 mg/mL injectable due to FDA inspectional findings regarding 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 and involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling L-Tryptophan 300 mg/mL injectable, all presentations, for intravenous and subcutaneous use. The product was compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, Michigan.
The recall was initiated due to FDA inspectional findings that raised concerns about quality control procedures impacting sterility assurance. The agency classified this recall as Class II.
The product was distributed nationwide in the United States. Patients who have received this medication should consult their healthcare provider regarding the recall and potential risks associated with the lack of sterility assurance.
The recalled product
- Product
- L-TRYPTOPHAN 300 MG/ML INJECTABLE, 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 (1)
- 02282013@12
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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