Red Mountain Compounding Pharmacy Recalls S-Methylcobalamin Injections for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Methylcobalamin injections due to a lack of assurance of sterility. The recall covers 60 vials distributed nationwide.
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. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in injectable drugs) are rated as Severe (4).
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Methylcobalamin 1,000mcg/mL MDV Injection. The recall involves 60 glass vials, consisting of 10ml and 30ml sizes, which were distributed nationwide in the USA. The specific reason for the recall is a lack of assurance of sterility.
The affected products include specific lots with expiration dates ranging from August 2019 to October 2019. The recall is classified as FDA Class II. No specific illnesses or injuries are reported in the source text.
Consumers and healthcare providers should stop using the recalled vials and contact the recalling firm for instructions on return or disposal. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only, Red mountain Compounding RX
- Category
- Drug — Injectable Medication
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 (11)
- Lot #: a) S05162019DH@10
- EXP 08/16/2019
- S05242019DT@07
- EXP 8/24/19
- S07182019DT@14 EXP 10/18/19
- b) S05162019DH@18
- Exp 8/16/19
- S07102019DT@04
- EXP 10/10/19
- S07262019DH@10 EXP 10/26/19
- S07292019DH@10 EXP 10/29/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain 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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