Qualitest Recalls Ranitidine Syrup Due to Preservative Stability Failure
Vintage Pharmaceuticals is recalling specific lots of Ranitidine Syrup because preservative levels failed stability specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Vintage Pharmaceuticals LLC, doing business as Qualitest Pharmaceuticals, is recalling 61,146 bottles of Ranitidine Syrup (15 mg/mL). The affected product is a prescription-only oral solution distributed nationwide in the United States.
The recall was initiated because the product failed stability specifications, specifically regarding out-of-specification results for the preservative butylparaben. The agency has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The affected lots are L088L13A (expiry 12/15), L023F14A (expiry 5/16), and L024F14A (expiry 5/16). Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.
The recalled product
- Product
- RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
- Category
- Drug — Prescription Medication
- Affected units
- 61,146
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 (6)
- Lot #: L088L13A
- Expiry: 12/15
- Lot #: L023F14A
- Expiry: 5/16
- Lot#: L024F14A
- Expiry: 5/16.
Distribution
Distributed nationwide across the United States.
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