S-methylcobalamin 25 mg/mL recall: Sterility Concern
S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19
Why was S-methylcobalamin 25 mg/mL recalled?
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 04232015@28, BUD 10/20/2015
- Product
- S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19
- Recalling firm
- The Apothecary Shoppe LLC
- Quantity
- 25.3 mL
- Distribution
- Oklahoma
- Recall date
- August 12, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)