FDA Recalls Tramadol Hydrochloride Tablets Due to Labeling Errors
Lake Erie Medical & Surgical Supply Inc. is recalling 16 cartons of Tramadol Hydrochloride 50 mg tablets due to incorrect or missing lot and expiration dates.
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 FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is limited to documentation and labeling errors.
Plain-English summary
Lake Erie Medical & Surgical Supply Inc. is recalling 16 paper cartons of Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only. The product is distributed by Quality Care Products in Temperance, MI, and manufactured by CSPC Ouyl Pharm Co., Ltd. in Shijazhuang, Hebei, China. The specific NDC number is 55700-0412-01.
The recall was initiated because the product has incorrect or missing lot and/or expiration dates. The affected lot number is 116289, with an expiration date of 09/20. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected units were distributed in Florida and Virginia. Consumers and healthcare providers should check their inventory for this specific product and lot number. If found, the product should be returned to the distributor or disposed of according to local regulations, as the labeling errors may affect traceability and safety verification.
The recalled product
- Product
- Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01
- Manufacturer
- Lake Erie Medical & Surgical Supply Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 16
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 # 116289
- Exp. 09/20
Distribution
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