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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Category
- Drug — Injectable
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
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.
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