Premier Pharmacy Labs Recalls Chlorpromazine Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling 824 vials of Chlorpromazine HCL Injection because an FDA inspection found insufficient environmental controls that may compromise 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 sterility assurance in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
Premier Pharmacy Labs Inc is voluntarily recalling 824 vials of ChlorproMAZINE HCL INJ, 25mg/mL, 1mL in a 5mL Sterile SDV. The product is distributed nationwide in the USA. The recall includes all lots remaining within their expiry dates.
The recall was initiated after an FDA inspection identified insufficient environmental controls, potential cross-contamination, and a lack of product-specific process validations. These deficiencies can result in a lack of sterility assurance for the medication.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or disposal. The recalled product is prescription-only.
The recalled product
- Product
- ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable Medication
- Affected units
- 824
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)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Premier Pharmacy Labs 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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