Specialty Medicine Compounding Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling methylcobalamin injectable products because sterility cannot be assured after a related product was found to be non-sterile.
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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the loss of sterility assurance for injectable products represents a significant risk of serious harm, aligning with the Severe criteria for high-risk products where injury has not yet been reported but the hazard is significant.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of methylcobalamin injectable products, including 10 mg/mL, 25 mg/mL, 1000 mcg/mL, and 5000 mcg/mL concentrations, as well as prefilled syringes. The recall covers 726.45 mL of product manufactured and distributed between July 1, 2013, and October 19, 2013.
The recall was initiated because the affected products were compounded in the same environment and under the same practices as another product that was found to be non-sterile. Consequently, the sterility of the recalled methylcobalamin products cannot be assured. The FDA has classified this as a Class II recall.
The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only. Patients and healthcare providers should stop using the recalled products and contact their healthcare provider for further instructions.
The recalled product
- Product
- METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine…
- Manufacturer
- Specialty Medicine 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 (20)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: t10072013@4
- 10192013@1
- 07112013@3
- 09052013@6
- 09262013@2
- 09272013@35
- 10012013@26
- 08282013@35
- t08282013@17
- t10092013@30
- t10102013@18
- t08222013@11
- t08292013@21
- t08302013@5
- t09162013@30
- 09162013@46
- 09172013@23
- t09242013@33
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Specialty Medicine 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 51 products in this recall →Related recalls
Same manufacturer · Specialty Medicine Compounding Pharmacy
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