John W Hollis Inc Recalls Testosterone Cypionate Injection Due to Sterility Concerns
John W Hollis Inc is recalling specific lots of Testosterone Cypionate for Injection because the products lack assurance of sterility.
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 an injectable product, which poses a significant risk of serious injury or death from infection.
Plain-English summary
John W Hollis Inc is recalling 50 mL vials of Testosterone Cypionate for Injection. The recall affects products with lot numbers 1157 (use by 09/16/14) and 2357 (use by 06/01/14). The products were distributed nationwide.
The recall was initiated due to a lack of assurance of sterility in the compounded aseptically filled injectable products. This means the manufacturer cannot guarantee that the medication is free from microorganisms.
Consumers and healthcare providers should stop using the affected products and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl Benzoate, Benzyl Alcohol, Rx Only, 10 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
- Manufacturer
- John W Hollis Inc
- Category
- Drug — Injectable Steroids
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 (4)
- lot# 1157
- Use by 09/16/14
- lot# 2357
- use by 06/01/14
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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