Premier Pharmacy Labs Recalls Orphenadrine Citrate Syringes Due to Sterility Concerns
Premier Pharmacy Labs is recalling 4,363 syringes of Orphenadrine Citrate Sterile Injectable Solution because FDA inspections found insufficient environmental controls that may compromise sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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 product, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Premier Pharmacy Labs Inc is recalling 4,363 syringes of Orphenadrine Citrate Sterile Injectable Solution, 30mg/mL, 1mL Sterile Single-Use Syringe. The product is identified by NDC 69623-104-10 and barcode 7 69623 10410 5. The recall covers all lots remaining within their expiration dates.
The recall was initiated following an FDA inspection that 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 injectable solution. The product was distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The product is prescription-only.
The recalled product
- Product
- Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-104-10, barcode 7 69623 10410 5.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 4,363
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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