John W Hollis Inc Recalls Methylcobalamin Injectable Due to Sterility Concerns
John W Hollis Inc is recalling Methylcobalamin 1000 mcg injectable products because they lack assurance of sterility. The recall covers Lot # 1862 distributed nationwide.
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 sterility assurance in injectable products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
John W Hollis Inc is recalling Methylcobalamin 1000 mcg for intramuscular or subcutaneous use. The product is a compounded aseptically filled injectable solution containing benzyl alcohol, sodium chloride, water, hydrochloric acid, and/or sodium hydroxide. The recall is limited to Lot # 1862, which was used by July 20, 2014.
The recall was initiated due to a lack of assurance of sterility in the compounded aseptically filled injectable products. The agency has classified this recall as Class II. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product immediately. The source text does not specify further instructions for disposal or replacement, but users should contact their healthcare provider or the recalling firm for guidance.
The recalled product
- Product
- METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg, Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
- Manufacturer
- John W Hollis Inc
- 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 (2)
- Lot # 1862
- used by 7/20/14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by John W Hollis Inc 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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