The Recall Desk
SevereFDA (Drugs)·D-0168-2019·Announced 2018-11-07

Pharm D Solutions Recalls Methylcobalamin Injectable Due to Sterility Concerns

Pharm D Solutions is recalling specific lots of Methylcobalamin 1 mg/mL injectable because the company cannot ensure the product is sterile.

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 assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Pharm D Solutions, LLC is recalling Methylcobalamin 1 mg/mL injectable, available in 10 mL and 30 mL vials, due to a lack of assurance of sterility. The recall covers specific lots distributed nationwide, including lot 04242018:27, 04302018:55, 03192018:33, and 05222018:28. The total quantity involved is 24,500 milliliters.

The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences. The primary hazard is the potential presence of non-sterile material in the injectable solution.

Healthcare providers and patients should stop using the affected lots immediately. Consumers should check their medication vials for the specific lot numbers and discard dates listed in the recall notice. If you have questions about this recall, contact Pharm D Solutions, LLC.

The recalled product

Product
Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injectable NDC 69699-1501-30, Pharm D Solutions, Houston, Texas
Affected units
24,500

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 (4)

  • Lot: a) 04242018:27 Discard by: 9/15/2018
  • 04302018:55 Discard by: 10/27/2018
  • b) 03192018:33 Discard by: 9/15/2018
  • 05222018:28 Discard by: 11/18/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Pharm D Solutions, LLC 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.

See all 79 products in this recall →