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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87364

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 18, 2021
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Zydus Pharmaceuticals (USA) Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.

D-0315-2021
Recall number
D-0315-2021
Initiated
February 18, 2021
Classification
Class I
Status
Terminated
Quantity
816 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization: customer complaints for crystallization in finished product.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: customer complaints for crystallization in finished product.

Code information

Lot#: L000155, Exp 12/2021; L000156, Exp 1/2022

Distribution pattern

USA Nationwide

drug · product 2 of 2

Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.

D-0316-2021
Recall number
D-0316-2021
Initiated
February 18, 2021
Classification
Class I
Status
Terminated
Quantity
1,638 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization: customer complaints for crystallization in finished product.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: customer complaints for crystallization in finished product.

Code information

Lot#: L000126, L000127, Exp 12/31/2021

Distribution pattern

USA Nationwide