Key Takeaway

Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27 by American Specialty Pharmacy was recalled on December 12, 2014. The hazard: Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product

FDA Drug Class II Terminated

Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27

Recalled: December 12, 2014 ~15 vials units affected D-0427-2015

Description

Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27

Hazard / Reason

Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27

Drugs

Company Information

American Specialty Pharmacy

Plano, TX, United States

View all 1 recalls by American Specialty Pharmacy →

Distribution

TX

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.