Qualitest Recalls Temazepam Capsules Due to Failed Stability Specifications
Vintage Pharmaceuticals is recalling 1,200 bottles of Temazepam 7.5 mg capsules because they failed stability specifications. The affected lot is distributed nationwide.
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 typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Vintage Pharmaceuticals LLC, doing business as Qualitest Pharmaceuticals, is recalling 1,200 bottles of Temazepam Capsules USP, 7.5 mg. The product is identified by NDC 0603-5891-21, lot number T248H15A, and an expiration date of 08/17. The recall was initiated because the product failed stability specifications.
The affected product was distributed nationwide. The recall is classified as Class III by the U.S. Food and Drug Administration, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers should stop using the recalled product and return it to their pharmacy or contact the recalling firm for further instructions.
The recalled product
- Product
- TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,200
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)
- T248H15A
- Exp. 08/17
Distribution
Distributed nationwide across the United States.
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