Olympia Pharmacy Recalls Betamethasone Sodium Phosphate Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Betamethasone Sodium Phosphate 12 mg/ml Injection because FDA inspections raised concerns about quality control and 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 assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Betamethasone Sodium Phosphate 12 mg/ml Injection. The product was compounded by Olympia Pharmacy in Orlando, FL, and distributed nationwide and to Puerto Rico. The specific lot affected is identified by code A5719 with an expiration date of 6/7/13.
The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the lack of assurance of sterility. The agency has classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Betamethasone Sodium Phosphate 12 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Injectable Steroid
- 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)
- A5719 Exp 6/7/13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 105 recalled by Lowlite Investments, Inc. D/B/A Olympia Pharmacy 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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