Olympia Pharmacy Recalls Diphenhydramine Injection Due to Sterility Concerns
Olympia Pharmacy is recalling Diphenhydramine 50 mg/ml Injection because FDA inspection findings 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are typically scored as 4 (Severe), especially when involving sterility concerns in injectable medications which carry significant risk.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling Diphenhydramine 50 mg/ml Injection. The product was compounded by Olympia Pharmacy in Orlando, FL. The recall affects one unit with code A3804 and an expiration date of 12/31/13.
The recall was initiated because FDA inspection findings resulted in concerns regarding quality control processes, specifically a lack of assurance of sterility. The distribution pattern for the recalled product was nationwide and Puerto Rico.
Consumers and healthcare providers should stop using the recalled product and contact Olympia Pharmacy for further instructions or a refund.
The recalled product
- Product
- Diphenhydramine 50 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)
- A3804 Exp 12/31/13
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.
See all 105 products in this recall →Related recalls
Same manufacturer · Lowlite Investments, Inc. D/B/A Olympia Pharmacy
See all →- SevereOlympia Pharmacy Recalls Diclazuril Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- HighOlympia Pharmacy Recalls Metabolase Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls Oxytocin Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls Betamethasone Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls HACC 270.1 Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
Same hazard · sterility concern
See all →- HighSegmental Stem Components for ELEOS Limb Salvage System Recalled
FDA (Devices) · 2025-06-04
- HighMEDIHONEY Dressing Applicator Pouch Recalled for Sterility Concerns
FDA (Devices) · 2024-10-16
- HighProparacaine Hydrochloride Eye Drops Recalled Due to Temperature Exposure
FDA (Drugs) · 2024-10-02
- HighExactech OPTETRAK Knee Implants Recalled for Out-of-Specification Vacuum Bag Packaging
FDA (Devices) · 2024-06-26
- HighPantoprazole Sodium for Injection Recalled Due to Sterility Concern
FDA (Drugs) · 2023-09-20
Similar recalls
- HighFDA Recalls Phenylephrine 1 mg/mL Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-06-01
- HighPyridoxine Injection Vials Recalled by FDA Due to Sterility Failure
FDA (Drugs) · 2022-06-01
- HighDexpanthenol 250 mg/mL Injectable Solution Recalled for Sterility Failure
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Sodium Tetradecyl Sulfate Injectable Over Sterility Assurance Failure
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Sodium Tetradecyl Sulfate Injection Due to Sterility Assurance Failure
FDA (Drugs) · 2022-06-01
- HighPyridoxine Injection Vials Recalled Due to Sterility Concerns
FDA (Drugs) · 2022-06-01