Phenylephrine Injectable Recalled Due to Manufacturing Quality Control Deviations
Olympia Compounding Pharmacy is recalling 4,521 vials of Phenylephrine 1 mg/mL due to manufacturing quality control failures. Environmental and personnel monitoring procedures were not properly investigated prior to October 1, 2021.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses Current Good Manufacturing Practice (CGMP) deviations in a compounding pharmaceutical facility, which constitutes a risk-of-harm situation. However, no illnesses, injuries, or deaths have been reported in the source material, limiting the severity to High rather than Severe.
Plain-English summary
Olympia Compounding Pharmacy is recalling 4,521 vials of Phenylephrine 1 mg/mL (NDC 73198-0021-05, Lot H47030, Beyond Use Date 8/30/2022) that were distributed nationwide. This is a prescription multi-dose injectable medication prepared by a compounding pharmacy.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Prior to October 1, 2021, the pharmacy failed to properly investigate excursions in environmental and personnel monitoring procedures that exceeded Out of Action Limits (OOAL). These monitoring failures raise concerns about potential manufacturing defects.
The recalled product
- Product
- Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0021-05.
- Affected units
- 4,521
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)
- Lot: H47030 BUD: 8/30/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by Olympia Compounding Pharmacy dba 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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