John W Hollis Inc Recalls Pyridoxine HCl Injectable Due to Sterility Concerns
John W Hollis Inc is recalling Pyridoxine HCl 100mg injectable products because they lack assurance of sterility. Consumers should stop using the product and contact their pharmacist.
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 infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
John W Hollis Inc is recalling Pyridoxine HCl 100mg, 30 mL injectable products. The recall is due to a lack of assurance of sterility in the compounded aseptically filled injectable products. The affected product is identified by Lot 2789 and has a best used by date of 7/10/14.
The product was distributed nationwide. The recall is classified as Class II by the FDA. The source text does not report any specific illnesses or injuries associated with this recall.
Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for further instructions. The recalling firm is John W Hollis Inc, located in Nashville, TN.
The recalled product
- Product
- PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: 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: 2789
- Best used by: 7/10/14
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.
See all 19 products in this recall →Related recalls
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