Taro Recalls Nortriptyline Hydrochloride Capsules Due to Manufacturing Deviations
Taro Pharmaceuticals is recalling 44,256 bottles of Nortriptyline Hydrochloride capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is CGMP deviations, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling 44,256 bottles of Nortriptyline Hydrochloride Capsules, USP equivalent to 10mg base. The product is manufactured by Taro Pharmaceutical Industries Ltd. in Haifa Bay, Israel, and distributed by Taro Pharmaceuticals U.S.A., Inc. in Hawthorne, New York. The recall was initiated on January 8, 2021, and was classified as Class II by the FDA.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected product includes NDC 51672-4001-1 and other related package codes, with lot numbers AC05096, AC05098, and AC05099, and an expiration date of 10/31/2022. The distribution pattern is nationwide.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. The recall status is currently Terminated, with a termination date of September 7, 2023. No specific instructions for consumer disposal are provided in the source text, but standard recall procedures apply.
The recalled product
- Product
- NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE HYDROCHLORIDE)
- Brand
- NORTRIPTYLINE HYDROCHLORIDE
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 44,256
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 (4)
- AC05096
- AC05098
- and AC05099
- Exp 10/31/2022
UPCs (3)
- 0351672400415
- 0351672400316
- 0351672400118
Distribution
Distributed nationwide across the United States.
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