Status
Completed
Drug Enforcement D-0248-2025
Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (AQL) inspection was not conducted on a statistically sound number of samples. This may result in the inability to assure that the impacted products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess and may lead to products of unacceptable quality.
Classification
Class II
Report Date
March 5, 2025
Termination Date
—
Product Information
- Product description
- Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01.
- Product quantity
- 1,147 syringes
- Reason for recall
- Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (AQL) inspection was not conducted on a statistically sound number of samples. This may result in the inability to assure that the impacted products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess and may lead to products of unacceptable quality.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Turbare Manufacturing
- Address
-
925 Jeanette Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0248-2025
- Event ID
- 96306
- Recall initiation date
- February 18, 2025
- Center classification date
- February 21, 2025
- Code info
- Lot #s: 12122024@2 (BUD: 3/12/2025); 12192024@2 (BUD: 4/18/2025).
- More code info
- —