TexasStar Pharmacy Recalls Baclofen Injection Due to Sterility Concerns
TexasStar Pharmacy is recalling 700 mL of Baclofen 2.5 mg/mL injection in 100 mL vials due to a lack of assurance of sterility. The product was distributed in Texas.
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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are typically scored as 4 (Severe), especially when involving potential sterility issues in injectable medications which carry significant risk if compromised.
Plain-English summary
TexasStar Pharmacy, located in Plano, Texas, is recalling 700 mL of Baclofen, 2.5 mg/mL INJ, in 100 mL vials. The recall involves 7 vials of 100 mL each. The product is prescription-only and was distributed in Texas.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility issue or report any illnesses or injuries associated with the product.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication. The affected lots include specific expiration dates and lot numbers as detailed in the recall notice.
The recalled product
- Product
- Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023
- Manufacturer
- TexasStar Pharmacy
- Category
- Drug — Injectable Medication
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 (8)
- Lot # 07142015#7192@1
- Exp 09/12/2015
- 09112015#7192@1
- Exp 11/10/2015
- 10082015#7192@9
- Exp 12/07/2015
- 11302015#71920@1
- Exp 1/30/2015
Distribution
Distributed in 1 state:
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