Olympia Pharmacy Recalls Acepromazine Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Acepromazine 25 mg/ml Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.
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 administered, meeting the criteria for a Severe rating.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy, located in Orlando, FL, is recalling Acepromazine 25 mg/ml Injection. The product was compounded by Olympia Pharmacy and distributed nationwide and to Puerto Rico. The specific lot affected is identified by code B0112 with an expiration date of 08/31/13.
The recall was initiated due to FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product. The agency has classified this recall as Class II.
Consumers and veterinary professionals who have this specific product should stop using it and contact Olympia Pharmacy or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Injectable
- 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)
- B0112 exp 08/31/13
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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