PHENYLephrine Injectable Syringe Recall Due to Insufficient Sterility Assurance
Central Admixture Pharmacy Services recalls 499,304 PHENYLephrine syringes nationwide because validation data for sterility decontamination cycles was lacking. No illnesses have been reported.
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: Class II FDA recall of a sterile injectable product with inadequate validation of sterilization decontamination cycles. No illnesses or injuries reported. Per the rubric, a high-risk product without reported harm scores 3 (High).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 499,304 pre-filled syringes of PHENYLephrine 1,000 mcg/10mL (100 mcg/mL in 0.9% sodium chloride), distributed nationwide. This is a prescription-only injectable medication.
The recall was initiated due to lack of assurance of sterility. Validation data for the decontamination cycles used in manufacturing was lacking, indicating the sterilization process had not been adequately validated.
Multiple lots with expiration dates from July 10, 2023 through September 6, 2023 are affected.
The recalled product
- Product
- PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- Affected units
- 499,304
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 (20)
- Lot: 36-239063
- 36-239064
- 36-239065
- 36-239066
- 36-239067
- 36-23906
- 736-239068
- 36-239069
- 36-239204
- Exp. 7/10/2023
- 36-239196
- 36-239197
- 36-239198
- 36-239199
- 36-239200
- 36-239201
- 36-239202
- 36-239203
- 36-239205
- 36-239206
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 recalled by Central Admixture Pharmacy Services, Inc. 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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