HF Acquisition Recalls Famotidine Injection Due to Temperature Abuse
HF Acquisition Co. LLC is recalling specific lots of Famotidine Injection because a customer reported the product was received in a non-refrigerated state.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences, and no illnesses or injuries are reported.
Plain-English summary
HF Acquisition Co. LLC is recalling Famotidine Injection, USP, 20 mg/2mL, 2 mL vials. The recall was initiated after a complaint was received from a customer stating that the product was received in a non-refrigerated state.
The affected product is identified by Lot # 6122639 with an expiration date of 08/2021. The vials were distributed to one consignee located in Connecticut.
Consumers and healthcare providers should stop using the affected product and contact HF Acquisition Co. LLC for further instructions or a replacement.
The recalled product
- Product
- FAMOTIDINE (FAMOTIDINE)
- Brand
- FAMOTIDINE
- Manufacturer
- HF Acquisition Co. LLC
- Category
- Drug — Prescription Drug
- 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 (2)
- Lot #: 6122639
- Exp. Date 08/2021
UPCs (1)
- 0363323739119
Distribution
Distributed in 1 state:
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