Teva Recalls Albuterol Sulfate Syrup Due to Foreign Particles
Teva North America is recalling 8,052 bottles of Albuterol Sulfate Syrup because black particles were found in the product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, an FDA Class II recall involving a significant hazard (foreign substance in a medication) corresponds to a severity score of 4 (Severe), as it is not explicitly Class I but involves a tangible physical defect in a drug product.
Plain-English summary
Teva North America is recalling 8,052 bottles of Albuterol Sulfate Syrup, 2 mg/5 mL, 473 mL bottles. The product is prescription-only and was manufactured in Canada by Contract Pharmaceuticals Limited for Teva Pharmaceuticals USA. The specific lot number is 95113, with an expiration date of 01/2017.
The recall was initiated due to the presence of a foreign substance, described as black particles. The source text identifies these particles generically as cellulose-based bundles of brown fibrous material. The FDA has classified this recall as Class II.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific NDC (0093-0661-16) and lot number. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16
- Manufacturer
- Teva North America
- Category
- Drug — Prescription Liquid
- Affected units
- 8,052
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 # 95113
- exp 01/2017
Distribution
Distributed nationwide across the United States.
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