FDA Recalls Amino Blend Injectable Vials Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling Amino Blend injectable vials due to lack of assurance of sterility. Approximately 7,761 vials were distributed nationwide. The FDA has classified this as a Class II recall.
What this means for you
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: This is an FDA Class II injectable medication with sterility assurance defects. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling Amino Blend injectable vials (NDC 73198-0129-30) due to lack of assurance of sterility. This is a prescription multi-dose 30 mL vial containing a blend of amino acids intended for injection.
Approximately 7,761 vials were distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands. The recalled lot codes are A24104, A24304 (beyond-use date 7/4/2022), A24303 (beyond-use date 7/3/2022), and B2422322, B24123-22 (beyond-use date 8/22/2022).
The U.S. Food and Drug Administration has classified this as a Class II recall. The recall was initiated due to lack of assurance of sterility.
The recalled product
- Product
- Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL 50 mg/mL Citrulline 50 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.NDC 73198-0129-30.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-defect
- contamination-risk
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 (5)
- Lots: A24104
- A24304 BUD: 7/4/2022
- A24303 BUD: 7/3/2022
- B2422322
- B24123-22 BUD: 8/22/2022
Distribution
Distributed nationwide across the United States.
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