Lyne Laboratories Recalls Cyproheptadine Hydrochloride Syrup Due to Subpotency
Lyne Laboratories is recalling specific lots of Cyproheptadine Hydrochloride Syrup because the product was found to be subpotent. The recall affects 12,215 bottles distributed in New Jersey.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is subpotency, which is a quality issue rather than a direct safety hazard like contamination or mislabeling of a dangerous substance.
Plain-English summary
Lyne Laboratories, Inc. is recalling 12,215 bottles of Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL. The product is packaged in amber glass 473 mL bottles with child-resistant screw closures and is distributed by Rising Pharmaceuticals, Inc. The specific lot number is CR1603, with an expiration date of 12/17.
The recall was initiated because the product was assayed and found to be out of specification (OOS) for cyproheptadine, indicating subpotency. This means the medication may not contain the full labeled amount of the active ingredient. The affected product was shipped to Rising Pharmaceuticals and distributed in New Jersey.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be discontinued and returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been using this medication.
The recalled product
- Product
- Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton
- Manufacturer
- Lyne Laboratories, Inc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 12,215
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 #: CR1603
- Exp 12/17
Distribution
Distributed in 1 state:
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