Bedford Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Bedford Pharmacy is recalling Testosterone Cypionate (Complete Formula) 200 mg/mL injections due to a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.
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 assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Bedford Pharmacy, located in Bedford, New Hampshire, is recalling Testosterone Cypionate (Complete Formula) 200 mg/mL injections. The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product consists of 2-vial packages with Lot # 09032015@16 and an expiration date of 10/18/2015. The recall is classified as Class II by the U.S. Food and Drug Administration.
The product was distributed in New Hampshire and Massachusetts. Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
- Manufacturer
- Bedford Pharmacy
- Category
- Drug — Injectable
- Affected units
- 2
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 #: 09032015@16
- Exp 10/18/2015
Distribution
Part of a larger recall action
This product is one of 13 recalled by Bedford 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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