Perrigo Recalls Clindamycin Oral Solution Due to Particulate Matter
Paddock Laboratories is recalling seven lots of Perrigo Clindamycin Palmitate Hydrochloride for Oral Solution due to the presence of particulate matter.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 II, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard is particulate matter, which is a quality defect rather than a high-risk pathogen or structural failure.
Plain-English summary
Paddock Laboratories, LLC is recalling seven lots of Perrigo Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml. The recall is being conducted because of the presence of particulate matter in the product.
The affected product is identified by NDC 0574-0129-01. The specific lots subject to the recall include lot numbers 2013313915, 2013374398, 2013323969, 2013364336, 2013323971, 2013364334, and 2013313913. These lots have expiration dates of August 2015 or September 2015.
The recall covers 156,012 bottles that were distributed nationwide. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots.
The recalled product
- Product
- Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01
- Manufacturer
- Paddock Laboratories, LLC
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 156,012
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 (7)
- 2013313915 Exp 08/15
- 2013374398 Exp 09/15
- 2013323969 Exp 08/15
- 2013364336 Exp 09/15
- 2013323971 Exp 08/15
- 2013364334 Exp 09/15
- 2013313913 Exp 08/15
Distribution
Distributed nationwide across the United States.
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