The Recall Desk
SevereFDA (Drugs)·D-1095-2020·Announced 2020-04-15

Innovative Compounding Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

Innovative Compounding Pharmacy is recalling specific lots of Methylcobalamin Injectable due to a lack of assurance of sterility. Patients in California, Maine, and Texas should stop using the product.

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 product, which poses a significant risk of infection and potential serious injury.

Plain-English summary

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy is recalling specific lots of Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable. The recall was initiated because of a lack of assurance of sterility for the affected products.

The affected lots are 02262020@51, 01032020@53, and 01162020@57. These products were distributed to patients in California, Maine, and Texas. The recall is classified as FDA Class II.

Patients who have received these specific lots should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Manufacturer
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Category
Drug — Injectable
Hazard

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 (6)

  • Lot #: 02262020@51
  • Expires after 05-26-2020
  • Lot # 01032020@53
  • Expires after 04-02-2020
  • Lot # 01162020@57
  • Expires after 04-15-2020

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 5 recalled by Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy 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 5 products in this recall →

Related recalls

Same manufacturer · Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

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Same hazard · infection

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