Dr. Reddy's Recalls Paricalcitol Capsules Due to Breakage and Leakage
Dr. Reddy's Laboratories is recalling 9,155 bottles of Paricalcitol capsules nationwide due to reports of breakage and leakage.
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 by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for packaging or cosmetic defects.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 9,155 bottles of Paricalcitol Capsules, 1 mcg, 30 capsules per bottle. The product is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in India and distributed nationwide.
The recall was initiated due to reports of breakage and leakage of the Paricalcitol capsules. The affected lots include C404795, C404796, C404797, C406272, C406273, C406274, C406518, C409586, C409587, C409588, C501835, C501836, C501837, C503797, C503798, C505009, C505568, and C505569, with expiration dates ranging from May 2016 to July 2017.
Patients and healthcare providers should check their inventory for these specific lot numbers and expiration dates. The FDA has classified this as a Class III recall, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- PARICALCITOL (PARICALCITOL)
- Brand
- PARICALCITOL
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Capsules
- Hazard
- Affected units
- 9,155
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 (20)
- Lot #s: C404795
- C404796
- C404797
- Exp 05/2016
- C406272
- C406273
- C406274
- C406518
- Exp 07/2016
- C409586
- C409587
- Exp 11/2016
- C409588
- Exp 12/2016
- C501835
- C501836
- C501837
- Exp 02/2017
- C503797
- C503798
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · PARICALCITOL
- LowDr. Reddy's Recalls Paricalcitol Capsules Due to Breakage and Leakage
FDA (Drugs) · 2016-02-24
- LowDr. Reddy's Recalls Paricalcitol Capsules Due to Breakage and Leakage
FDA (Drugs) · 2016-02-24
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